Precision Clinical Laboratory

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on an unannounced on-site revisit survey on 10/26/2023, a record review, and an interview with the laboratory manager, the laboratory failed to perform and document calibration verification for the electrolytes on the Siemens Dimension chemistry analyzer and the Tosoh Hemoglobin A1c analyzer since 2021. Findings include: 1. A record review revealed the laboratory failed to perform calibration verification for the electrolytes (sodium, potassium, chloride) on the Siemens Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Dimension EXL analyzer and hemoglobin A1c on the Tosoh since 2021. 2. The laboratory performed approximately 87,000 chemistry tests per year. 3. An interview on 10/26/2023, at approximately 4:00 PM, with the laboratory manager, confirmed the laboratory failed to perform calibration verification for the electrolytes and the hemoglobin A1c analytes. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on an unannounced on-site revisit survey on 10/26/2023 and an interview with testing personnel, the laboratory failed to test two levels of coagulation quality control samples every 8 hours of operation for Prothrombin time (PT) and Partial Thromboplastin time (PTT) during patient testing since the last survey on 7/26/2023. Findings include: 1. A record review of coagulation quality control printouts revealed that the laboratory failed to test two levels of quality control every 8 hours for PT and PTT since the last survey on 7/26/2023. 2. An interview on 10/26/2023, at approximately 2:30 PM, with the testing personnel, confirmed that they were unaware that quality control material must be performed every 8 hours of patient testing. D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) The technical supervisor is responsible for establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results. This STANDARD is not met as evidenced by: Based on an unannounced on-site revisit survey on 10/26/2023, laboratory records review and an interview with the laboratory manager, the Technical Supervisor (TS) failed to verify that the quality control procedures were established for Prothrombin time (PT), Partial Thromboplastin time (PTT), Clostridium difficile (CDiff), and Excyte M Erythrocyte Sedimentation Rate (ESR) since the last survey on 12/17/2020. Findings include: 1. A review of laboratory records revealed the laboratory failed to test two levels of coagulation quality control (QC) for Prothrombin time (PT) and Partial Thromboplastin time (PTT) every 8 hours of patient testing. (See D5545) 2. A review of laboratory records revealed that the TS failed to ensure the unassayed coagulation QC data statistics for the reference range study was performed prior to testing patient samples and available for review at the time of the survey. (See D3031) 3. A review of laboratory records revealed that the TS failed to ensure that QC procedures for the ESR, CDiff and coagulation testing were followed by testing personnel. 4. A review of laboratory records revealed that the TS failed to document -- 2 of 3 -- or retain the lot numbers and expiration dates of reagents and QC materials for CDiff, PT, PTT, and ESR. 5. An interview with the laboratory manager on 10/26/2023 at 4: 45 PM confirmed that the TS failed to establish QC procedures for the tests. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was completed on July 26, 2023. It was determined that Immediate Jeopardy (IJ) existed for the following condition level deficiencies: 42 C.F. R. 493.801 Condition: Enrollment and testing of [proficiency testing] 42 C.F.R. 493.1101 Condition: Facility Administration 42 C.F.R. 493.1230 Condition: General laboratory systems 42 C.F.R. 493.1240 Condition: Preanalytic systems; 42 C.F.R. 493.1250 Condition: Analytic systems; 42 C.F.R. 493.1290 Condition: Postanalytic systems; 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director 42 C.F.R. 493.1447 Condition: Laboratories performing high complexity testing; technical supervisor D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on the deficiencies cited here in, the Condition of Enrollment and Testing of Samples was not met. The laboratory failed to enroll in proficiency testing (see D2001), authorize the proficiency testing program to release proficiency testing results (see D2005), failed to test proficiency (see D2006), failed to maintain all documents in the handling, preparation, testing, and reporting of PT samples (see D2015). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 22 -- D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) and an interview with the laboratory manager, the laboratory failed to enroll in PT for the analytes gram stain, mycology identification, and human immunodeficiency virus (HIV) since the last survey on 12 /17/2020. Findings include: 1. A review of PT records from the American Proficiency Institute (API) revealed the laboratory failed to enroll in PT for gram stain, mycology, and HIV since the last survey on 12/17/2020. The laboratory performed approximately 750 microbiology tests and 30 HIV tests in 2022. 2. An interview with the laboratory manager on 07/20/2023, at approximately 5:05 PM, confirmed the laboratory failed to enroll in PT for gram stain, mycology, and HIV. D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) and an interview with the laboratory manager, the laboratory failed to authorize American Proficiency Institute (API) to release the PT results to HHS for all analytes in the specialties of hematology, chemistry, immunology, and microbiology since the last survey on 12/17/2020. Findings include: 1. A review of PT records from the American Proficiency Institute (API) and a review of the Casper 0155D report, revealed the laboratory failed to authorize API to release the PT results to HHS for all testing performed in the specialties of hematology, chemistry, immunology, and microbiology since the last survey on 12/17/2020. 2. The laboratory performs approximately 125,000 patient tests per year. 3. An interview with the laboratory manager on 07/19/2023, at approximately 10:45 AM, confirmed the laboratory failed to notify API to release the PT results to HHS. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up -- 2 of 22 -- until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT), laboratory PT records, and an interview with the laboratory manager, the laboratory failed to test the American Proficiency Institute (API) microbiology samples in the same manner as patient testing since the last survey on 12/17/2020. Findings include: 1. A review of PT records from the API and a review of laboratory PT records, revealed the laboratory failed to test the microbiology samples for organism identification and Clostridium difficile (CDiff) the same way as patient testing. 2. The laboratory performed testing on patient samples for CDiff by manual test kit method and also performed by molecular assay on the BD Max. There were no records or documentation in the laboratory that reflected which platform the PT samples were tested. 3. The laboratory performed approximately 750 microbiology tests per year. 4. An interview with the laboratory manager on 07/20/2023, at approximately 5:05 PM, confirmed the laboratory failed to test and report API microbiology samples the same manner as patient tests. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing (PT) records and an interview with the laboratory manager, the laboratory failed to maintain all documents in the handling, preparation, testing, and reporting of PT samples from the American Proficiency Institute (API), and the laboratory director failed to sign the attestation statements for API in the specialties of hematology, chemistry, and microbiology since the last survey on 12/17/2020. Findings include: 1. A review of the laboratory PT documents revealed the laboratory failed to maintain all documents from API, instrument printouts, and intermediate test records for the manual tests Clostridium difficile (CDiff), urine microscopy, and microbiology culture workups. 2. A review of the PT documents from API and the laboratory records, revealed the laboratory director failed to sign the API attestation statements and did not delegate the responsibility for the specialties of hematology, chemistry, and microbiology. 3. An interview with the laboratory manager on 07/20/2023, at approximately 5:05 PM, confirmed the laboratory failed to maintain PT sample testing records and the laboratory director failed to sign the attestation statements. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 -- 3 of 22 -- Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on the deficiencies cited here in, the Condition of Facility Administration was not met. The laboratory failed be constructed and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized (see D3003), and retain quality control and patient test records, including instrument printouts, for at least 2 years (see D3031). D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on a record review, an observation, and an interview with the laboratory manager, the laboratory failed to ensure there was no patient specimen or environmental contamination in the laboratory where microbiology cultures and BD Max molecular tests were performed since the last survey on 12/17/2020. Findings include: 1. An observation on 7/19/2023, at approximately 10:30 AM, revealed the microbiology department failed to have a biological safely hood for the processing and testing of urine, stool, nasal, and sputum samples. 2. A record review of the BD Max reference manual revealed the necessity of the performance of wipe tests to determine whether there is environmental contamination or cross-over contamination. 3. An interview with the laboratory manager on 7/19/2023, at approximately 10:30 AM, confirmed the laboratory did not perform wipe tests to ensure there was no contamination. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the laboratory's records for the Vitek and BD Max analyzers, microbiology records, and an interview with the laboratory manager, the laboratory failed to retain documentation of instrument quality control, instrument maintenance, -- 4 of 22 -- patient test printouts; quality control and patient microbiology culture workups, gram stains, and bacitracin susceptibility; patient worksheets for the manual test kit Clostridium difficile (CDiff), quality control, lot number and expiration dates for manual kits CDiff, Campylobacter, Human Immunodeficiency Virus (HIV), Candida, and Escherichia coli Shiga toxin kit (EHEC) since the last survey on 12/17/2020. Findings include: 1. A record review of the microbiology identification and sensitivity reports from the Vitek revealed the laboratory did not retain the Vitek 2 instrument printouts for patient microbiology specimens for identification and susceptibility testing, as well as quality control testing, and maintenance performance. The Vitek 2 did not contain a back-up system and the internal memory holds 30 days of activity. 2. A record review of the microbiology culture workups revealed the laboratory failed to document and retain testing records for gram stain quality control and patient testing, as well as culture workups to include the lot numbers and expiration dates of reagents, type of media, quality control, bacitracin sensitivity, dates of testing and personnel who performed the test. 3. A record review of the microbiology documents revealed the laboratory failed to document and maintain records that include quality control, lot numbers and expiration dates for the manual test kits for CDiff, HIV, and EHEC. 4. A review of the laboratory worksheet for CDiff revealed 4 out of 4 patients tested were not performed at the laboratory, but sent to another laboratory for testing on July 17, 2023. 5. The laboratory failed to document and retain any testing records for Candida species and there was no evidence the laboratory was testing for Candida, although results were reported with the BD Max urine panel assay since March 2023. The lab performed approximately 750 urine samples. 6. The laboratory performs approximately 750 microbiology tests per year. 7. An interview with the laboratory manager on 07/19/2023, at approximately 4:00 PM, confirmed the Vitek instrument reports and the BD Max results were not accessible or retained. The laboratory manager also confirmed that the laboratory failed to document and retain all testing records in the microbiology department, and that 4 patient stool samples for CDiff testing were performed at another laboratory and not at PCL. In addition, Candida was reported on all patient urine panel assays from the BD Max when no testing records were found in the laboratory. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the deficiencies cited herein, the Condition for General Laboratory Systems was not met. The laboratory failed to review and evaluate the results obtained on proficiency testing (see D5211) and failed to document proficiency testing evaluation and verification activities (see D5221) since the last survey on 12/17/2020. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing -- 5 of 22 -- performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the laboratory's written policies, proficiency testing (PT) records, and an interview with the laboratory manager, the laboratory failed to follow its procedure to document and review the evaluation of scores obtained from the American Proficiency Institute (API) for all tests performed in the specialties of hematology, chemistry, and microbiology since the last survey on 12/17/2020. Findings include: 1. Review of the laboratory's General and Safety Standard Operating Procedure (SOP) manual (GEN027 Proficiency Testing Protocol, effective 10/13/2022) and available American Proficiency Institute (API) records revealed that the laboratory failed to follow the SOP for evaluating and documenting the results evaluation for test scores which were not graded or scored. 2. The laboratory performs approximately 125,000 patient tests annually. 3. An interview with the laboratory manager on 07/19/2023, at approximately 11:30 AM, confirmed that the laboratory had no processes in place to review, evaluate, or document PT test sores. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the laboratory's General and Safety Standard Operating Procedure (SOP) manual, proficiency testing (PT) records, and an interview with the laboratory manager, the laboratory failed to document the evaluation and verification of all unsatisfactory scores and the

Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on direct observation, and Testing Personnel (TP) #2 interview, the laboratory failed to be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. Findings include: 1. Direct observation of the laboratory space on May 10, 2021, at approximately 10:00 AM, showed untidy work areas and inadequate workbench space. 2. Observation of TP #2 test performance on May 10, 2021, at approximately 11:15 AM showed equipment tops being used as workbench space. 3. Interview with TP #2 on May 10, 2021, at approximately 11:30 AM confirmed that the laboratory failed to have adequate space and workbenches in all areas. 4. The laboratory performs approximately 131,160 tests annually. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Based on the number and severity of the deficiencies cited herein, the Condition: Analytic Systems was not met. The laboratory failed to have written microbiology procedure manuals available to laboratory personnel (see D5401), failed to follow the manufacturer's instructions for it's prothrombin time reagent used on the ACL Elite coagulation analyzer to test patient prothrombin time (PT) specimens (see D5411), failed to monitor and document the temperature of the refrigerator where patient samples were stored and failed to define the acceptable temperature ranges on the temperature document for the molecular testing laboratory (see D5413), failed to replace laboratory supplies when they had exceeded their expiration date (see D5417), failed to establish control procedures or develop an Individualized Quality Control Plan (IQCP) to check each batch or shipment of microbiology agar media before or concurrent with initial use (see D5445), failed to have documented quality control for its C. difficile, HIV, Influenza, and Strep A testing (see D5449), failed to check each lot number of gram-negative and gram-positive identification and susceptibility cards for the Vitek for positive and negative reactivity from the period reviewed since December 2020 (see D5471). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on direct observation, and Testing Personnel (TP) #2 interview, the laboratory failed to have written microbiology procedure manuals available to laboratory personnel. Findings include: 1. On May 10, 2021, at approximately 1:00 PM the following tests kits, were observed: Alere C.difficile Tox A/B Quik Chek, Alere HIV- 1/2 Ag/Ab Combo, McKesson Consult Influenza A & B Test, McKesson Rapid Test Kit Consult Strep A Test. 2. No procedure manuals were available for these tests upon request. 3. Interview with TP #2 on May 10, 2021, at approximately 2:00 PM, confirmed that the laboratory failed to have these procedure manuals available to laboratory personnel. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, observation, lack of laboratory records, and interview with Testing Personnel (TP) #2, the laboratory failed to follow the manufacturer's instructions for it's prothrombin time reagent used on the ACL Elite coagulation analyzer to test patient prothrombin time (PT) specimens. Findings include: 1. On May 10, 2021, at approximately 12:10 PM the PT reagent HemosIL RecombiPlasTin 2G (lot # N0504540) that expires on May 01, 2022, was observed -- 2 of 5 -- being used on the ACL Elite analyzer. 2. Review of the reagent package insert for the PT reagent HemosIL RecombiPlasTin 2G (lot # N0504540) that expires on May 01, 2022, showed that the required International Sensitivity Index (ISI) value for the ACL Elite analyzer was 1.030. 3. On May 10, 2021, at approximately 12:12 PM the PT reagent HemosIL RecombiPlasTin 2G (lot # N0495565) that expired on January 01, 2021, with an ISI value of 1.020 was programed on the ACL Elite analyzer. 4. No normal patient prothrombin mean study was available upon request. 5. Interview with TP #2 on May 10, 2021, at approximately 12:20 PM, confirmed that the laboratory failed to performed a patient prothrombin mean study according to the manufacture's instructions and failed to update the lot # and ISI value on the ACL Elite analyzer for the current PT reagent being used. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with the Testing Personnel (TP) #4, the laboratory failed to monitor and document the temperature of the refrigerator where patient samples were stored and failed to define the acceptable temperature ranges on the temperature document for the molecular testing laboratory. Findings include: 1. On May 10, 2021, at 10:15 AM, an observation of the Accucold refrigerator revealed the refrigerator temperature was not monitored and was used for storing one patient urine specimen. 2. A record review of the molecular lab where Sars-CoV-2 test were performed revealed the laboratory failed to identify the appropriate temperature ranges for the test systems on the temperature recording document. 3. An interview on May 10, 2021, at 12:10 PM, with TP #4, confirmed that the temperature log failed to state the acceptable temperature ranges for the molecular test systems. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on the direct observation of supplies stored in the microbiology department refrigerator, and Testing Personnel (TP) #3 interview, the laboratory failed to replace laboratory supplies when they had exceeded their expiration date. Findings include: 1. Direct observation of the microbiology department refrigerator on May 10, 2021, at approximately 11:25 AM, showed a box with 6 sleeves (10 agar plates each) of MacConkey agar (lot #1021838) that expired on April 23, 2021. 2. Direct observation -- 3 of 5 -- of the microbiology department Narco 1000 CO2 incubator on May 10, 2021, at approximately 11:30 AM, showed 4 patients have been plated using the expired MacConkey media. 3. Interview with TP #3 on May 10, 2021, at approximately 2:20 PM, confirmed that the laboratory failed to discard the expired media before its expiration date and use it for patient testing. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a record review and interview with Testing Personnel (TP) #3, the laboratory failed to establish control procedures or develop an Individualized Quality Control Plan (IQCP) to check each batch or shipment of microbiology agar media before or concurrent with initial use. Findings include: 1. A review of microbiology documents revealed the laboratory failed to have quality control procedure or IQCP for the quality control checks of the MacConkey and Blood Agar media before using on patient specimens. 2. On May 10, 2021, at 12:30 PM, an interview with TP #3 confirmed the laboratory failed to have a quality control procedure or IQCP for the microbiology media. 3. The laboratory performs approximately 360 patient urine specimens a year. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on direct observation, and Testing Personnel (TP) #2 interview, the laboratory failed to documented quality control for its C. difficile, HIV, Influenza, and Strep A testing. Findings include: 1. On May 10, 2021, at approximately 1:00 PM the following tests kits, were observed in the laboratory: Alere C.difficile Tox A/B Quik Chek, Alere HIV-1/2 Ag/Ab Combo, McKesson Consult Influenza A & B Test, McKesson Rapid Test Kit Consult Strep A Test. 2. No quality control records were available for these tests upon request. 3. Interview with TP #2 on May 10, 2021, at approximately 2:05 PM, confirmed that the laboratory failed to have these quality control records available. D5471 CONTROL PROCEDURES -- 4 of 5 -- CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with Testing Personnel (TP) #3, the laboratory failed to check each lot number of gram-negative and gram-positive identification and susceptibility cards for the Vitek for positive and negative reactivity from the period reviewed since December 2020. Findings: 1. The laboratory failed to demonstrate a positive and negative reaction for each gram-negative and gram- positive identification and susceptibility card since December 2020. 2. An interview on May 10, 2021, at 12:30 PM, with TP #3, confirmed the laboratory failed to perform quality control procedures that demonstrated a positive and negative reaction for each gram-positive and gram-negative identification and susceptibility card used on the Vitek. 3. The laboratory performed 17 patient urine specimens on the Vitek Identification and Antibiotic Susceptibility Testing instrument since April 23, 2021. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory directory, the laboratory director failed to ensure quality control procedures were established for the Vitek Identification and Antibiotic Susceptibility Testing instrument, Alere test kits, Clostridium difficule and HIV Ag/Ab Combo, McKesson Consult Streptococcus and Influenza A/B test kits, microbiology agar media, and the Prothrombin time /International normalized ratio (INR) performed on the ACL Elite instrument. Findings: 1. A record review of the quality control documents in the microbiology department revealed the laboratory failed to maintain quality control procedures for test systems in microbiology. 2. A record review of quality control records for the Vitek revealed the laboratory failed to perform quality control on the gram-negative and gram-positive cards for Vitek identification and susceptibility system, microbiology agar media, HIV test kit and the Clostridium difficile test kit. 3. A record review revealed the laboratory director failed to ensure the correct International Sensitivity Index (ISI) value for the ACL Elite analyzer. 4. An interview on May 10, 2021, at 1:20 PM, with the laboratory director confirmed procedures for the quality control systems were not established. -- 5 of 5 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on the number and severity of the deficiencies cited herein, the Condition: Enrollment and Testing of Proficiency Testing Samples was not met. The laboratory failed to test proficiency testing samples in the same manner as it tests patient specimens (see D2006), and test proficiency testing samples the same number of times that it routinely tests patient samples (see D2010). D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 22 -- This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records, instrument test records, Standard Operating Procedures (SOP), patient test results and laboratory staff interview, the laboratory failed to test American Proficiency Institute (API), the laboratory's PT provider, PT samples in the same manner as its patient specimens for the second and third proficiency testing events of 2019 in the subspecialty of routine chemistry. The findings include: a. The laboratory tested its API routine chemistry PT samples for the second proficiency testing event of 2019 on June 3, 2019. b. For the second proficiency testing event of 2019, the laboratory reported to API five analytes, direct bilirubin, total iron, LDL cholesterol (calculated), sodium, and thyroid stimulating hormone (TSH), as "suspended." c. For the second proficiency testing event of 2019, API scored the laboratory's reported PT test results as 100% for the analytes the laboratory reported as "suspended." d. However, on June 3, 2019, the laboratory tested and reported two patient specimens for sodium (lab accession numbers 62052 and 62115), and tested and reported one patient specimen for TSH (lab accession number 62115) indicating that the laboratory had not "suspended" patient testing for sodium and TSH. e. The laboratory tested its API routine chemistry PT samples for the third proficiency event of 2019 on September 5, 2019 and again on September 6, 2019. The tests on both days were performed by the same testing person. f. The laboratory's proficiency testing results from both days were reviewed by the Technical Supervisor on September 6, 2019. g. The Technical Supervisor averaged test results obtained from the September 5 and 6, 2019 test runs to obtain the final proficiency test results reported to API. h. For the third proficiency testing event of 2019, the laboratory reported to API six analytes, direct bilirubin, total iron, LDL cholesterol (calculated), HDL cholesterol, total cholesterol, and phosphorus, as "suspended." i. However, on September 5, 2019, the laboratory tested and reported one patient specimen (lab accession number 69423) for total cholesterol, LDL cholesterol (calculated), and HDL cholesterol, and on September 6, 2019, the laboratory tested and reported one patient specimen (lab accession number 69539) for total cholesterol, LDL cholesterol (calculated), and HDL cholesterol indicating that the laboratory had not "suspended" patient testing for total cholesterol, LDL cholesterol (calculated), and HDL cholesterol. j. The laboratories PT SOP states: - No Inter-Laboratory Comparison will occur. - All PT samples will be run the same as patients. - PT samples will be run by all testing personnel. - PT samples will only be run once. k. On May 21, 2019 at approximately 4:00 pm, the laboratory Technical Supervisor confirmed that sodium, TSH, total cholesterol, LDL cholesterol (calculated), and HDL cholesterol were reported to API for the second and third PT events of 2019 as "suspended" even though the laboratory continued to test and report these test results for patient specimens, and also confirmed that PT samples for the second and third proficiency testing events of 2019 were not tested in the same manner consistent with the established SOP and in the same manner as the laboratory tests patient specimens. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records, instrument test records, Standard -- 2 of 22 -- Operating Procedures (SOP), patient test results and laboratory staff interview, the laboratory failed to test American Proficiency Institute (API), the laboratory's PT provider, PT samples the same number of times that it routinely tests patient samples. The findings include: a. On September 5 and 6, 2019, the laboratory tested its API routine chemistry PT samples for the third proficiency event of 2019. The Technical Supervisor averaged test results obtained from the September 5 and 6, 2019 test runs to obtain the final proficiency test results reported to API. b. On May 21, 2019 at approximately 4:00 pm, the Technical Supervisor confirmed that PT samples for the second and third proficiency testing events of 2019 were not tested in the same manner consistent with the established SOP and in the same manner as the laboratory tests patient specimens. (See D2006). D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on the number and severity of the deficiency cited herein, the Condition: Successful Participation in Proficiency Testing was not met. The laboratory failed to achieve satisfactory proficiency testing scores in two of three 2019 proficiency testing events for the analyte chloride resulting in unsuccessful chloride proficiency testing performance (see D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API), the laboratory's proficiency testing provider, proficiency testing reports and Technical Supervisor interview, the laboratory failed to achieve satisfactory performance for chloride in two consecutive proficiency testing events or two out of three consecutive proficiency testing events in -- 3 of 22 -- 2019 resulting in unsuccessful chloride proficiency testing performance. The findings include: a. A review of the laboratory's proficiency testing records indicated that for the first proficiency testing event of 2019, the laboratory received an unsatisfactory chloride proficiency testing score of 40%. In addition, for the second proficiency testing event of 2019, the laboratory received an unsatisfactory chloride proficiency testing score of 20% constituting unsuccessful chloride proficiency testing performance. b. On May 18, 2020 at 4:00 pm, the Technical Supervisor stated that the unsatisfactory proficiency testing score for the first proficiency testing event of 2019 was due to clerical error, and the unsatisfactory proficiency testing score for the second proficiency testing event of 2019 was due to lack of reagents to perform chloride testing. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on the number and severity of the deficiencies cited here in, the Condition: Facility Administration was not met. The laboratory failed to be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process (see D3001), be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized (see D3003), be constructed, arranged, and maintained to ensure molecular amplification procedures that are not contained in closed systems have a uni-directional workflow to include separate areas for specimen preparation, amplification, product detection, and reagent preparation (see D3005), retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years (see D3027), and retain quality control and patient test records, including instrument printouts, for at least 2 years (see D3031). D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on patient test record review, direct observation, and Technical Supervisor interview, the laboratory failed to be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of patient COVID-19 Polymerase Chain Reaction (PCR) testing. The findings include: a. The -- 4 of 22 -- Standard Operating Procedure (SOP) for the laboratory's COVID-19 (Coronavirus) PCR test procedure stated: "6. In the clean reagent preparation room prepare the master mix," "10. Before moving the plate to the nucleic acid handling area. . .," and "11. In the nucleic acid extraction room. . ." b. No separate areas, rooms, or hood existed as suggested in the laboratory's SOP above. One single "AirScience" laminar airflow hood was noted in the one room the laboratory used for nucleic acid extraction, master mix preparation, and PCR plate setup. c. According to laboratory records, the laboratory performed and reported approximately 40 patients COVID-19 test results from April 13, 2020 to May 19, 2020. d. On May 21, 2020 at approximately 3:00 pm, the Technical Supervisor confirmed that the room the laboratory utilized for its patient COVID-19 testing was not consistent with the laboratory's SOP. D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on review of the BGI Genomics manufacturers documentation and Technical Supervisor interview, the laboratory failed to have constructed, arranged and maintained the COVID-19 laboratory in such a manner to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized when performing patient testing. The findings include: a. One single "AirScience" laminar airflow hood is used for storing equipment, reagents and other supplies for use in the nucleic acid extraction process, master mix preparation and PCR plate setup for COVID-19 testing. b. The BGI Genomics manufacturer's instructions states "clean and decontaminate all work surfaces, pipettes, centrifuges and other equipment prior to use. Decontamination agents should be used including 10% bleach, 70% ethanol, and DNAzap or RNase Away to minimize the risk of nucleic acid contamination." 3. c. Laboratory personnel decontaminate the work area by using "Cloroxwipes 4. d.Approximately 40 patients have been tested for COVID- 19 since April 13, 2020. 5. e. The Technical Supervisor confirmed on May 21, 2020 at approximately 3:00 pm that the decontamination process utilized by the lab personnel is not consistent with the manufacturer's instructions. D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on direct observation and Technical Supervisor interview, the laboratory failed to be constructed, arranged, and maintained in such a manner to ensure that molecular amplification procedures for the laboratory's patient COVID-19 test, that was not contained in closed systems, had a uni-directional workflow to include separate areas for specimen preparation, amplification, product detection, and reagent preparation. -- 5 of 22 -- The findings include: a. For its patient COVID-19 Polymerase Chain Reaction (PCR) test, the laboratory had a room that contained the Applied Bioscience 7500 Real Time PCR System for molecular amplification, and another room that contained the "AirScience" laminar airflow hood used by the laboratory for reagent preparation, nucleic acid extraction, master mix preparation, and PCR plate set up. b. According to laboratory records, the laboratory performed and reported approximately 40 patient COVID-19 test results from April 13, 2020 to May 19, 2020. c. On May 21, 2020 at approximately 3:00 pm, the Technical Supervisor confirmed that the areas utilized for its patient COVID-19 PCR testing was not contained in a closed system and did not have a uni-directional workflow. D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: Based on patient record review and Technical Supervisor interview, the laboratory failed to retain patient test requisitions and test authorizations for its patient COVID- 19 testing for approximately 40 patients tested from April 13, 2020 to May 19, 2020 for at least 2 years. The findings include: a. The laboratory maintained no records of test requisitions or laboratory patient reports for its patient COVID-19 testing performed from April 13, 2020 to May 19, 2020. b. On May 19, 2020 at approximately 3:00 pm, the Technical Supervisor confirmed that no test requisitions or laboratory patient reports were available and that the laboratory only provided verbal patient COVID-19 test results. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: 1. Based on review of the laboratory's Vitek 2 instrument test printouts, and patient microbiology test reports, Technical Supervisor and Testing Personnel interview, the laboratory failed to retain instrument test printouts documenting the testing of two patient urine microbiology identification and susceptibility results reported between May 1, 2020 and May 4, 2020. The findings include: a. The laboratory used the Vitek 2 instrument to perform patient urine microbiology identification and susceptibility testing. b. Records of patient test results from the Vitek 2 were stored in the Vitek 2 instrument for retrieval and reporting. c. Patient test results obtained from the Vitek 2 instrument were manually entered into the laboratory's information system by the testing person. d. One patient urine sample, (lab accession number 83196) which had been collected on April 23, 2020, test result was performed using the Vitek 2 instrument and reported on May 4, 2020 as Proteus mirabilis including susceptibility results. e. One patient urine sample, (lab accession number 83080) which had been collected on April 21, 2020, test result was performed using the Vitek 2 instrument -- 6 of 22 -- and reported on May 1, 2020 as Escherichia coli including susceptibility results. f. Both patient test results were manually entered into the laboratory's information system by the Technical Supervisor on the reporting dates indicated. g. The Vitek 2 instrument did not have any record of either patient being tested and of the test results the laboratory reported. h. On May 21, 2020 at approximately 2:00 pm, Testing Personnel #1 confirmed that no Vitek instrument testing records existed for either patient, that all records of tests performed on the Vitek 2 instrument were retained in the instrument, and that both patient Vitek 2 instrument test results indicated above were manually entered by the Technical Supervisor in the laboratory's information system for reporting. The laboratory could not authenticate the test results reported. 2. Based on review of patient COVID-19 test records, direct observation, and Technical Supervisor interview, the laboratory failed to retain quality control (QC) and patient test records, that included instrument printouts, for approximately 40 patient COVID- 19 specimens tested from April 13, 2020 to May 19, 2020. The findings include: a. The laboratory maintained no records pertaining to QC and patient specimen testing results for its patient COVID-19 testing performed and reported from April 13, 2020 to May 19, 2020. b. On May 21, 2020 at approximately 4:00 pm, the Technical Supervisor confirmed that the laboratory was unable to provide any COVID-19 QC and patient test records due to the fact the laboratory's information system for its COVID-19 testing was in the process of being developed. D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on the number and severity of the deficiencies cited herein, the Condition: Bacteriology was not met. The laboratory failed to have an adequate manual system in place to ensure patient bacteriology test results were accurately and reliably sent from the point of data entry to final report destination (see D5801), and follow written policies and procedures for an ongoing mechanism to monitor, and assess, when indicated, correct problems identified in the bacteriology postanalytic systems (see D5891). D5010 VIROLOGY CFR(s): 493.1205 If the laboratory provides services in the subspecialty of Virology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1265, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on the number and severity of the deficiencies cited herein, the Condition: Virology was not met. The laboratory failed to have a written COVID-19 procedure manual that included specimen collection, labeling, storage, preservation, transportation, and criteria for specimen acceptability and rejection, step-by-step performance of the procedure,

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of the laboratory's written policies, proficiency testing (PT) records and technical consultant interview, the laboratory failed to enroll in an HHS-approved PT program for the first PT testing event in 2017 for the specialty and subspecialty testing for which it seeks certification. Findings include: a. The laboratory's policy for proficiency testing (#GEN.0011, effective 6-3-16) states, "All sections of Precision Clinical Laboratory shall be enrolled in external proficiency testing surveys for the extent of testing performed as required by regulatory agencies." b. The laboratory tests patient specimens in the specialties/subspecialties of routine chemistry, endocrinology, hematology, and coagulation. c. No documentation existed to show that the laboratory had enrolled in a PT program, so the laboratory received no PT samples to test for the 1st event of 2017. d. On 4-10-18 at around 2 p.m., the technical consultant confirmed he could not provide any documentation that the laboratory had enrolled in a PT program in time to receive and test any PT samples for the 1st event of 2017. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 25 -- The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the laboratory's written policies, proficiency testing (PT) records, and staff interview, the laboratory failed to ensure PT attestation statements were signed by the appropriate personnel for the hematology and chemistry testing modules in 2017. Findings include: a. The laboratory's policy for proficiency testing (#GEN.0011, effective 6-3-16) states, "The proficiency testing attestation page is signed by the laboratory director or designee and the individual performing the testing." b. The laboratory's written policy (Proficiency Testing Protocol #550) states, "The laboratory director and testing personnel are required to sign/date the attestation page." and, "Ensure to file a copy of the signed attestation statement in the manual, as well." c. Records showed neither the lab director nor any testing personnel had signed the attestation statements for the 2nd and 3rd hematology PT events of 2017 and the 3rd chemistry PT event of 2017. d. On 4/10/18 at around 2 p.m., the technical consultant confirmed the attestation statements had not been signed by appropriate personnel as required by laboratory policy and the federal CLIA regulations. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, proficiency testing (PT) records and staff interview, the laboratory failed to document each step in the testing and reporting of results by not retaining a duplicate copy of the PT results sent to the PT provider for the 3rd event of 2017 and the 1st event of 2018. Findings include: a. The laboratory's policy for proficiency testing (#GEN.0011, effective 6-3-16) for submission of PT results states, "Once entered, a second individual should confirm clerical entry from the final result forms/printouts and print the confirmation of receipt page from the CAP website" and "All PT records and