Wash. Admin. Code § 246-338-090
The medical test site must use quality control procedures, providing and assuring accurate and reliable test results and reports, meeting the requirements of this chapter.
(1) The medical test site must have and follow written procedures and policies available in the work area for:
(a) Analytical methods used by the technical personnel including:
(2) The medical test site must establish written criteria for and maintain appropriate documentation of:
(3) The medical test site must maintain documentation of:
(a) Expiration date, lot numbers, and other pertinent information for:
(4) For quantitative tests, the medical test site must perform quality control as follows:
(5) For qualitative tests, the medical test site must perform quality control as follows:
(6) The medical test site must:
(d) Use the manufacturer's reference material limits for assayed material, provided they are:
(7) The medical test site must perform, when applicable:
(b) Validation for moderate complexity testing by verifying the following performance characteristics when the medical test site introduces a new procedure classified as moderate complexity:
(c) Validation for high complexity testing:
(iii) By verifying the following performance characteristics:
(8) When patient values are above the maximum or below the minimum calibration point or the reportable range, the medical test site must:
(b) Use an appropriate procedure to rerun the sample allowing results to fall within the established linear range.
Table 090-1 General Quality Control Requirements
| Control Material | Frequency | ||||
| (a) | Each batch or shipment of reagents, discs, antisera, and identification systems | • | Appropriate control materials for positive and negative reactivity | • | When prepared or opened, unless otherwise specified |
| (b) | Each batch or shipment of stains | • | Appropriate control materials for positive and negative reactivity | • | When prepared or opened; and |
| • | Each day of use, unless otherwise specified | ||||
| (c) | Fluorescent and immunohistochemical stains | • | Appropriate control materials for positive and negative reactivity | • | Each time of use, unless otherwise specified |
| (d) | Quality control for each specialty and subspecialty | • | Appropriate control materials; or | • | At least as frequently as specified in this section; |
| • | Equivalent mechanism to assure the quality, accuracy, and precision of the test if reference materials are not available | • | More frequently if recommended by the manufacturer of the instrument or test procedure; or | ||
| • | More frequently if specified by the medical test site | ||||
| (e) | Direct antigen detection systems without procedural controls | • | Positive and negative controls that evaluate both the extraction and reaction phase | • | Each batch, shipment, and new lot number; and |
| • | Each day of use |
Table 090-2 Calibration and Calibration Verification—Moderate and High Complexity Testing
| Calibration Material | Frequency | |||
| calibration | • | Calibration materials appropriate for methodology | • | Initial on-site installation/implementation of instrument/method; |
| • | At the frequency recommended by the manufacturer; and | |||
| • | Whenever calibration verification fails to meet the medical test site's acceptable limits for calibration verification. | |||
| calibration verification | • | Use assayed material, if available, at the lower, mid-point, and upper limits of procedure's reportable range; or | • | At least every six months; |
| • | Demonstrate alternate method of assuring accuracy at the lower, mid-point, and upper limits of procedure's reportable range | • | When there is a complete change of reagents (i.e., new lot number or different manufacturer) is introduced; | |
| • | When major preventive maintenance is performed or there is a replacement of critical parts of equipment; or | |||
| • | When controls are outside of the medical test site's acceptable limits or exhibit trends. |
(9) The medical test site must perform quality control procedures as described for each specialty and subspecialty in (a) through (l) of this subsection.
(a) Chemistry.
Perform quality control procedures for chemistry as described in Table 090-3 or follow an equivalent quality testing procedure that meets federal CLIA regulations.
Table 090-3 Quality Control Procedures—Chemistry
| Subspecialty/Test | Qualitative | Quantitative | |||||||
| Control Material | Frequency | Control Material | Frequency | ||||||
| Routine Chemistry | • | Positive and negative reference material | • | Each day of use | • | Two levels of reference material in different concentrations | • | Each day of use | |
| Toxicology | |||||||||
| • | GC/MS for drug screening | • | Analyte-specific control | • | With each run of patient specimens | • | Analyte-specific control | • | With each analytical run |
| • | Urine drug screen | • | Positive control containing at least one drug representative of each drug class to be reported; must go through each phase of use including extraction | • | With each run of patient specimens | ||||
| Urinalysis | |||||||||
| • | Nonwaived instrument | • | Two levels of control material | • | Each day of use | ||||
| • | Refractometer for specific gravity | • | Calibrate to zero with distilled water | • | Each day of use | ||||
| • | One level of control material | ||||||||
| Blood Gas Analysis | • | Calibration | • | Follow manufacturer's specifications and frequency | |||||
| • | One level of control material | • | Each eight hours of testing, using both low and high values on each day of testing | ||||||
| • | One-point calibration or one control material | • | Each time patient specimen is tested, unless automated instrument internally verifies calibration every 30 minutes | ||||||
| Electrophoresis | • | One control containing fractions representative of those routinely reported in patient specimens | • | In each electrophoretic cell | • | One control containing fractions representative of those routinely reported in patient specimens | • | In each electrophoretic cell |
(b) Hematology.
(iii) Perform quality control procedures for hematology as described in Table 090-4 or follow an equivalent quality testing procedure that meets federal CLIA regulations.
Table 090-4 Quality Control Procedures—Hematology
| Control Material | Frequency | |||
| Automated | • | Two levels of reference material in different concentrations | • | Each day that patient samples are tested |
| Manual Blood Counts | • | One level of reference material | • | Every eight hours that patient samples are tested |
| Qualitative Tests | • | Positive and negative reference material | • | Each day of testing |
(c) Coagulation.
(iii) Perform quality control procedures for coagulation as described in Table 090-5 or follow an equivalent quality testing procedure that meets federal CLIA regulations.
Table 090-5 Quality Control Procedures—Coagulation
| Control Material | Frequency | |||
| Automated | • | Two levels of reference material in different concentrations | • | Every eight hours that patient samples are tested; and |
| • | Each time reagents are changed | |||
| Manual Tilt Tube Method | • | Two levels of reference material in different concentrations | • | Every eight hours that patient samples are tested; and |
| • | Each time reagents are changed |
(d) General immunology.
(iii) Perform quality control procedures for general immunology as described in Table 090-6 or follow an equivalent quality testing procedure that meets federal CLIA regulations.
Table 090-6 Quality Control Procedures—General Immunology
| Control Material | Frequency | |||
| Serologic tests on unknown specimens | • | Positive and negative reference material | • | Each day of testing |
| Kits with procedural (internal) controls | • | Positive and negative reference material (external controls) | • | When kit is opened; and |
| • | Procedural (internal) controls | • | Each day of testing, or follow an equivalent quality testing procedure that meets federal CLIA regulations | |
| • | Each time patient sample is tested |
(e) Syphilis serology.
(f) Microbiology.
(i) Have available and use:
(iii) For antimicrobial susceptibility testing:
(v) For commercial media:
(vi) For microbiology subspecialties:
(A) Bacteriology: Perform quality control procedures for bacteriology as described in Tables 090-7 and 090-8.
Table 090-7 Quality Control Procedures—Bacteriology
| Control Material | Frequency | |||
| Reagents, disks, and identification systemsCatalase, coagulase, oxidase, and Beta-lactamase CefinaseTM reagentsBacitracin, optochin, ONPG, X and V disks or strips | • | Positive and negative reference organisms, unless otherwise specified | • | Each batch, shipment, and new lot number unless otherwise specified |
| Stains, unless otherwise specified; DNA probes; and all beta-lactamase methods other than CefinaseTM | • | Positive and negative reference organisms | • | Each batch, shipment, and new lot number; and |
| • | Each day of use | |||
| Fluorescent stains | • | Positive and negative reference organisms | • | Each batch, shipment, and new lot number; and |
| • | Each time of use | |||
| Gram stains | • | Positive and negative reference organisms | • | Each batch, shipment, and new lot number; and |
| • | Each week of use | |||
| Direct antigen detection systems without procedural controls | • | Positive and negative controls that evaluate both the extraction and reaction phase | • | Each batch, shipment, and new lot number; and |
| • | Each day of use | |||
| Test kits with procedural (internal) controls | • | Positive and negative reference material (external) controls | • | Each batch, shipment, and new lot number; and |
| • | Procedural (internal) controls | • | Each day of testing, or follow an equivalent quality testing procedure that meets federal CLIA regulations | |
| • | Each time patient sample is tested | |||
| Antisera | • | Positive and negative reference material | • | Each batch, shipment, and new lot number; and |
| • | Every six months |
Table 090-8 Quality Control Procedures—Bacteriology - Media for Antimicrobial Susceptibility Testing
| Control Material | Frequency | |||
| Check each new batch of media and each new lot of antimicrobial disks or other testing systems (MIC) | • | Approved reference organisms (ATCC organisms) | • | Before initial use and each day of testing; or |
| • | May be done weekly if the medical test site can meet the quality control requirements for antimicrobial disk susceptibility testing as outlined by CLSI M100S Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Sixth Edition. |
(B) Mycobacteriology: Perform quality control procedures for mycobacteriology as described in Table 090-9.
Table 090-9 Quality Control Procedures—Mycobacteriology
| Control Material | Frequency | |||
| All reagents or test procedures used for mycobacteria identification unless otherwise specified | • | Acid-fast organism that produces a positive reaction and an acid-fast organism that produces a negative reaction | • | Each day of use |
| Acid-fast stains | • | Acid-fast organism that produces a positive reaction and an organism that produces a negative reaction | • | Each day of use |
| Fluorochrome acid-fast stains | • | Acid-fast organism that produces a positive reaction and an acid-fast organism that produces a negative reaction | • | Each time of use |
| Susceptibility tests performed on Mycobacterium tuberculosis isolates | • | Appropriate control organism(s) | • | Each batch of media, and each lot number and shipment of antimycobacterial agent(s) before, or concurrent with, initial use |
| • | Each week of use |
(C) Mycology: Perform quality control procedures for mycology as described in Table 090-10.
Table 090-10 Quality Control Procedures—Mycology
| Control Material | Frequency | |||
| Susceptibility tests: Each drugnote: Establish control limits and criteria for acceptable control results prior to reporting patient results | • | One control strain that is susceptible to the drug | • | Each day of use |
| Lactophenol cotton blue stain | • | Appropriate control organism(s) | • | Each batch or shipment and each lot number |
| Acid-fast stains | • | Organisms that produce positive and negative reactions | • | Each day of use |
| Reagents for biochemical and other identification test procedures | • | Appropriate control organism(s) | • | Each batch or shipment and each lot number |
| Commercial identification systems utilizing two or more substrates | • | Organisms that verify positive and negative reactivity of each media type | • | Each batch or shipment and each lot number |
(D) Parasitology:
(I) Have available and use:
• Reference collection of slides or photographs and, if available, gross specimens for parasite identification; and
• Calibrated ocular micrometer for determining the size of ova and parasites, if size is a critical parameter.
(E) Virology:
(I) Have available:
• Host systems for isolation of viruses; and
• Test methods for identification of viruses that cover the entire range of viruses that are etiologically related to the clinical diseases for which services are offered; and
(i) Processing specimens:
(ii) Performing specimen examinations:
(iii) Establish and implement a quality assurance program that ensures:
(E) Rescreening of benign gynecological slides is:
(III) Performed and documented on:
• No less than 10 percent of the benign gynecological slides; and
• Includes cases selected at random from the total caseload and from patients or groups of patients that are identified as having a high probability of developing cervical cancer, based on available patient information;
(F) The technical supervisor:
(i) Perform ABO grouping, Rh (D) typing, antibody detection and identification, and compatibility testing as described by the Food and Drug Administration (FDA) under 21 C.F.R. Parts 606 and 640.
(A) Perform ABO grouping:
(ii) Blood and blood products:
(A) Collecting, processing, and distributing:
(C) Storing:
(D) Collection of heterologous or autologous blood products on-site:
(E) Retention of samples of transfused blood:
(iv) Promptly investigate transfusion reactions according to established procedures, and take any necessary remedial action.
Table 090-11 Quality Control Procedures—Immunohematology
| Reagent | Control Material | Frequency | ||
| ABO antisera | • | Positive control | • | Each day of use |
| Rh antisera | • | Positive and negative controls | • | Each day of use |
| • | Patient control to detect false positive Rh test results | • | When required by the manufacturer | |
| Other antisera | • | Positive and negative controls | • | Each day of use |
| ABO reagent red cells | • | Positive control | • | Each day of use |
| Antibody screening cells | • | Positive control using at least one known antibody | • | Each day of use |
(j) Histocompatibility.
(k) Cytogenetics.
(i) Document:
(iii) Use an adequate patient identification system for:
(l) Radiobioassay and radioimmunoassay.
[Statutory Authority: RCW 70.42.220. WSR 25-02-002, s 246-338-090, filed 12/18/24, effective 12/28/24. Statutory Authority: RCW 70.42.220, 43.70.041, and 42 C.F.R. 493.1291(l), 1832, 1241(b), 1299, 1256 (2)(iv, v), 1273(a). WSR 16-18-073, § 246-338-090, filed 9/2/16, effective 10/3/16. Statutory Authority: RCW 70.42.005 and 42 C.F.R. Part 493. WSR 05-04-040, § 246-338-090, filed 1/27/05, effective 3/19/05. Statutory Authority: RCW 70.42.005, 70.42.060. WSR 01-02-069, § 246-338-090, filed 12/29/00, effective 1/29/01. Statutory Authority: RCW 70.42.005, 70.42.060 and chapter 70.42 RCW. WSR 00-06-079, § 246-338-090, filed 3/1/00, effective 4/1/00. Statutory Authority: RCW 70.42.005. WSR 97-14-113, § 246-338-090, filed 7/2/97, effective 8/2/97. Statutory Authority: Chapter 70.42 RCW. WSR 93-18-091 (Order 390), § 246-338-090, filed 9/1/93, effective 10/2/93; WSR 91-21-062 (Order 205), § 246-338-090, filed 10/16/91, effective 10/16/91. Statutory Authority: RCW 43.70.040. WSR 91-02-049 (Order 121), recodified as § 246-338-090, filed 12/27/90, effective 1/31/91. Statutory Authority: Chapter 70.42 RCW. WSR 90-20-017 (Order 090), § 248-38-090, filed 9/21/90, effective 10/22/90.]