Carolina Community Behavorial Services Lab

Summary Statement of Deficiencies D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory procedures, review of 2019 American Proficiency Institute (API) proficiency testing (PT) records, review of patient records, review of manufacturer's instructions, interview with sales representative and surveyor observation 9/24/19, the laboratory failed to meet all specified requirements for the performance of urine drug screen testing on the Diatron Pictus 500 chemistry analyzer. Findings: The laboratory performs urine toxicology screen testing on the Diatron Pictus 500 chemistry analyzer for the following analytes; Amphetamines (AMPH), Cocaine (COC), Opiate (OPI), Oxycodone (OXY) and Cannabinoid (THC). Urine specimens are then frozen and later sent out to a reference laboratory for confirmation testing. 1. The laboratory failed to participate in the 2019 API 1st PT event for Chemistry-Miscellaneous to verify the accuracy of the urine drug screen testing. See D5217. 2. The laboratory failed to establish and/or follow policies and procedures for specimen storage, the conditions for specimen transportation, the criteria for specimen acceptability and rejection, procedures for specimen processing, and the criteria for specimen referral. See D5311. 3. The laboratory failed to monitor, document and/or define the correct criteria for the room temperature and humidity, and the refrigerator and freezer temperatures used to store and freeze urine specimens before they are sent out for drug confirmation testing. See D5413. 4. The laboratory failed to discard supplies that had exceeded their expiration date. See D5417. 5. The laboratory failed to establish performance specifications for interfering substances for the testing performed on the Diatron Pictus 500 chemistry analyzer. See D5423. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of 2019 American Proficiency Institute (API) proficiency testing (PT) records, absence of documentation, review of patient records, and observation 9 /24/19, the laboratory failed to participate in a system to verify accuracy of the urine drug screen test results. Findings: Review of the 2019 API Order confirmation revealed the laboratory enrolled in PT for Urine Drug Screen and Urine Adulteration Test on 3/20/19. The API order confirmation revealed the 1st PT event for Chemistry- Miscellaneous shipped to the facility on 4/22/19. There was no documentation present that the 1st PT event was tested. During tour of the lab at approximately 11:15 a.m., surveyor observed the unopened API PT samples in the laboratory's refrigerator. Review of patient records revealed patient testing was performed in January, February, March and April, 2019. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, review of manufacturer's instructions, review of "Urine Test Request" forms, surveyor observation and interview with service representative 9/24/2019, the laboratory failed to establish and/or follow policies and procedures for specimen storage, the conditions for specimen transportation, the criteria for specimen acceptability and rejection, procedures for specimen processing, and the criteria for specimen referral. Findings: 1. The laboratory failed to establish procedures for urine specimen storage that meet all manufacturer's instructions for each analyte. Review of laboratory procedure manual revealed copies of manufacturer's instructions for each analyte. Review of manufacturer's instructions revealed the analytes tested in the urine drug screen have different refrigeration requirements for the length of time in which urine specimens can be stored. For example: a. The manufacturer's instructions for the analyte COC, "Thermo Scientific DRI Cocaine Metabolite Assay", state "Specimens kept at room temperature that do not receive initial test within 7 days of arrival at the laboratory may be placed into a secure refrigerator unit at 2 to 8 degrees celcius (C) for up to two months.". b. The manufacturer's instructions for the analyte THC, "Thermo Scientific DRI Cannabinoid Assay", state "Specimens kept at room temperature that do not receive initial test within 7 days of arrival at the laboratory may be placed into a secure refrigerator unit at 2 to 8 degrees C for up to 4 weeks." 2. The laboratory failed to establish procedures for the conditions required for specimen transport. Review of laboratory procedure, "Standard Operations Manual for Lab" revealed "(name of -- 2 of 10 -- reference lab) will handle all training for shipping of specimen for confirmation to their laboratory prior to shipping any specimen. See shipment guidelines provided by (name of reference lab) for shipment." The name of the reference laboratory in the procedure is not the same name as the reference laboratory on the test order slip used by the facility for confirmation drug testing. The procedure manual did not include shipment guidelines. Interview with service representative at approximately 11:00 a. m. confirmed the laboratory sends urine specimens to the reference laboratory listed on the test order slip for confirmation drug testing and not the reference laboratory noted in the laboratory procedure. Review of reference laboratory web site and test order slip from reference lab revealed no instructions or guidelines for the transportation of urine specimens for confirmation drug testing. 3. The laboratory failed to establish criteria for specimen acceptability and rejection. a. Review of laboratory procedure, "Standard Operations Manuel for Lab" revealed the procedure explains methods used to detect adulterated urine specimens, but does not state what should be accepted or what should be rejected. Also, many methods listed in the procedure as a means for detecting adulterations are not used by the laboratory. For example: a. The procedure states "Adulteration &(and) Dilution Detection...Means to detect adulteration by the collector and/or the laboratory include the following: 1. Specimen Temperature...2. Urine Appearance and Odor...3. Creatinine...4. Specific Gravity...5. PH (potential of Hydrogen)...6. Visible Blood..." and "Creatinine:..." Normal" random urine specimens will generally have urine creatinine levels of greater that 20 milligrams per deciliter (mg/dl)...levels below 2.0 mg/dl are usually a result of "dipping"...". The procedure does not state what should be accepted or rejected. b. Review of manufacturer's package inserts for opiate and cannabinoid assays revealed "Samples within a pH range of 3 to 11 are suitable for testing with this assay." Review of laboratory records revealed the laboratory performs specimen temperature testing only and does not perform creatinine, specific gravity, or pH testing. Interview with service representative at approximately 11:00 a.m. confirmed the laboratory does not perform creatinine, specific gravity or pH testing and also confirmed the laboratory performs specimen temperature testing as a means of detecting adulteration of the urine specimen. 4. The laboratory failed to follow and/or establish procedures for specimen processing. a. Review of laboratory procedure "Standard Operations Manual for Lab" revealed "Urine Collection Procedure...6. Upon receipt of the specimen from the donor, immediately apply the temperature strip (if applicable) to the outside of the bottle. If using a drug screen test request form, record the urine temperature on the form. NOTE: Urine temperature should be measured within (4) four minutes of collection and should read between 90-100 degrees Fahrenheit...1. Specimen Temperature...The urine temperature should be noted on Urine Test Request form.". Review of random "Urine Test Request" forms, sample identification numbers 211 and 131, revealed no urine temperatures were documented. b. Review of manufacturer's package inserts for all analytes tested revealed "It is recommended that grossly turbid specimens be centrifuged before analysis." Surveyor observation revealed the laboratory does not have a centrifuge. Interview with service representative at approximately 11:00 a.m. confirmed the laboratory does not have a centrifuge and does not have a policy for the acceptance or rejection of turbid specimens. 5. The laboratory failed to establish criteria for the referral of urine drug screen confirmation testing. a. Review of laboratory procedure manual revealed no policy or procedure defining the criteria the laboratory has established for urine drug screen confirmation referrals. Phone interview with owner and provider at approximately 1:15 p.m. confirmed all urine drug screens were sent out for confirmation testing. b. Review of laboratory procedure manual revealed the laboratory had not established a system for tracking urine drug screens that were sent out for confirmation drug testing. For example; there was no log in which specimens -- 3 of 10 -- sent out for drug confirmation testing were recorded and no system for verifying whether the confirmation report was received and reviewed by the provider. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)