Beaver County Hospital Authority

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/25,26,27,28/2025. The laboratory was found out of compliance with the following CLIA Conditions: 493.1213; D5022: Toxicology, High Complexity 493.1441; D6076: Laboratory Director, High Complexity The findings were reviewed with the chief executive officer, laboratory director, technical consultant, and testing person #2 at the conclusion of the survey. 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 a review of records, urine drug screen package insert, FDA database, email correspondence with FDA representative, and interview with the technical consultant, the laboratory failed to ensure the requirements were met for the subspecialty of toxicology for ten of ten months of patient testing. Findings include: (1) The laboratory failed to verify the accuracy for the iCassette Urine Test - Drug Screen Cassette at least twice annually. Refer to D5217; (2) The laboratory failed to establish the performance specifications for the iCassette Urine Test - Drug Screen Cassette not cleared or approved by the FDA. Refer to D5423; (3) The laboratory failed to perform a negative and positive control material each day of patient urine drug screen testing. Refer to D5449. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, 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 -- consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policies, and interview with the technical consultant, the laboratory failed to establish a written clinical consultant competency assessment policy, based on the position responsibilities as listed in the Subpart M. Findings include: (1) A review of written policies and interview with the technical consultant on 03/25/2025 at 02:40 pm identified no evidence of a policy for assessing the competency of the clinical consultant; (2) A review of Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of March 2023 through the current date identified no documentation competency assessments had been performed based on position responsibilities for one of one clinical consultant; (3) The findings were reviewed with the technical consultant on 03/25/2025 at 02:49 pm, who confirmed the laboratory failed to define and perform assessments based on the specific position responsibilities. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to review and evaluate proficiency testing results for one of three Hematology Proficiency testing events reviewed in 2024. Findings include: (1) A review of Hematology Proficiency testing records for three events (First 2024, Second 2024, and Third 2024) identified the following failure with no evidence that

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/27,28,29/2023, The laboratory was found out of compliance with the following CLIA Conditions: 493.1409; D6033: Technical Consultant The findings were reviewed with the hospital administrator, interim laboratory manager, and testing person #2 at the conclusion of the survey. 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 records and interview with the interim laboratory manager, the testing person(s) failed to sign a proficiency testing attestation statement for one of three chemistry core proficiency testing events reviewed in 2022. Findings include: (1) On 03/27/2023 a review of chemistry core proficiency testing records for 2022 identified the following for one of three events: (a) Third 2022 Event - The attestation statement had not been signed by the testing person(s). (2) The findings were reviewed with the interim laboratory manager who stated on 03/27/2023 03:09 pm the attestation statement had not been signed by the testing person(s). D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on interview with the interim laboratory manager and testing person #2, the laboratory failed to provide written instructions to clients collecting and referring routine Hematology, Chemistry and Urinalysis testing. Findings include: (1) On 03/27 /2023 at 02:47 pm, the laboratory manager stated the following: (a) Routine Chemistry testing was performed using the Ortho Vitros 350 analyzer; (b) Routine CBC (Complete Blood Count) testing was performed using the Sysmex XS-1000i analyzer; (c) PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing were performed using the Sysmex CA-660 analyzer; (d) The laboratory performed urine sediment examinations; (e) Specimens were transported to the laboratory from a local long term care facility. (2) Interview with the interim laboratory manager and testing person #2 on 3/29/23 at 11:30 am confirmed the laboratory did provide written instructions (i.e.,client service manual) to the client to explain the laboratory's specimen handling policies. 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 a review of records, manufacturer's instructions, and interview with the interim laboratory manager and testing person #2, the laboratory failed to follow the manufacturer's instructions for implementing coagulation reagents for two of two lot numbers. Findings include: (1) On 03/28/2023 at 11:00 am, the interim laboratory manager stated: (a) The laboratory began using the Sysmex CA-660 analyzer to perform PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing for adults on 04/18/2022; (b) The following reagent lot numbers were put into use on 04/18/2022: (i) PT - Innovin reagent, lot #564605 (ii) PTT - Actin FSL reagent, lot #562683 (2) A review of the manufacturer's instructions contained in the "Sysmex Installation Package" for establishing the reference intervals stated: (a) "Donors must be from a health population"; (b) "Donors should span the age range of the population being tested"; (3) A review of the implementation records for the PT and PTT reagents identified the following: (a) PT Innovin Reagent (i) Although the laboratory had tested 22 samples (11 males and 11 females), there was no documentation of the medication history and health status to ensure the donors were from a healthy population; (ii) There was no documentation of the age of the donors to ensure they spanned the adult age range. (b) PTT Actin FSL Reagent (i) Although the laboratory had tested 22 samples (11 males and 11 females), there was no documentation of the medication history and health status to ensure the donors were from a healthy population; (ii) There was no documentation of the age of the donors to ensure they spanned the adult age range. (4) The records were reviewed -- 2 of 8 -- with testing person #2 who stated on 03/28/2023 at 01:20 pm, the laboratory had not followed the manufacturer's instructions for the implementing the reagents as shown above. 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 a review of records, manufacturer's instructions, and interview with the interim laboratory manager, the laboratory failed to ensure the humidity was maintained as required by the manufacturer of the Sysmex XS-1000i and Sysmex CA- 660 analyzers for nine of 13 months reviewed. Findings include: (1) On 03/27/2023 at 02:50 pm, the interim laboratory manager stated CBC (Complete Blood Count) testing was performed using the Sysmex XS-1000i analyzer; (2) On 03/28/2023 at 11:00 am, the interim laboratory manager stated the laboratory began using the Sysmex CA660 analyzer to perform PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing for adults on 04/18/2022; (3) On 03/29 /2023 review of the manuals for the test systems identified the following: (a) Sysmex XS-1000i - The manual titled, "Instructions for Use" in Section 11.11 "Installation Environment" stated "Relative humidity should be in the range of 30-85%"; (b) Sysmex CA600 - The manual titled, "Instructions for Use" in Section 4.2 "Installation Environment" stated "Use the instrument at a relative humidity range of 30-85%". (4) A review of the laboratory humidity records from February 2022 through February 2023 identified the humidity readings were less than 30% for nine of 13 months as follows: (a) February 2022 - 28 of 28 humidity readings were documented as less than 30%; (b) March 2022 - 30 of 31 humidity readings was documented as less than 30%; (c) April 2022 - 20 of 30 humidity readings was documented as less than 30%; (d) May 2022 - One of 31 humidity readings was documented as less than 30%; (e) October 2022 - Ten of 31 humidity readings was documented as less than 30%; (f) November 2022 - 23 of 30 humidity readings was documented as less than 30%; (g) December 2022 - 31 of 31 humidity readings was documented as less than 30%; (h) January 2023 - 31 of 31 humidity readings was documented as less than 30%; (i) February 2023 - 28 of 28 humidity readings was documented as less than 30%. (4) The records were reviewed with the interim laboratory manager who stated on 03/29 /2023 at 09:45 am the laboratory humidity had not been maintained as required by the manufacturer as shown above. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) -- 3 of 8 -- (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with the interim laboratory manager and testing person #2, the laboratory failed to utilize the demonstrated reportable range for one of two new test methods; and failed to ensure the performance specification data had been evaluated prior to implementing the new testing for one of two new test methods introduced into the laboratory. Findings include: MINII SED ANALYZER (1) On 03/28/2023 at 10:30 am, testing person #2 stated the laboratory obtained a replacement miniiSED analyzer and began using it for patient testing on 08/20/2022; (2) A review of the performance specification records for the analyzer identified the laboratory had demonstrated a reportable range of 2-77 mm/hr; (3) Interview with testing person #2 on 03/28/2023 at 11:20 am confirmed the laboratory was using the reportable range of 4-99 mm/hr, which had been demonstrated with the previous analyzer instead of the reportable range that had been demonstrated by the laboratory for the replacement analyzer. SYSMEX CA-660 (1) On 03/27/2023 at 02:40 pm, the interim laboratory manager stated the laboratory began using the Sysmex CA-660 analyzer to perform PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing on 04/18/2022; (2) A review of the performance specification records for the new test system identified no evidence the data had been signed and dated as approved by the laboratory prior to putting into use for patient testing; (3) Interview with the interim laboratory manager on 03/28/2023 at 02:55 pm confirmed there was no documentation to prove the performance specification data had been reviewed and approved by the laboratory prior to putting into use. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the interim laboratory manager and testing person #2, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures for three of three analyzers reviewed from 05/01/2022 through 02/28/2023. Findings include: SYSMEX XS-1000i (1) On 03/27/2023 at 02:50 pm, the interim laboratory manager stated CBC (Complete Blood Count) testing was performed using the Sysmex XS-1000i analyzer; (2) On 03/28/2022, a review of the manufacturer's maintenance log showed the following required weekly maintenance procedure: (a) "Power Down IPU" (3) A review of maintenance logs from 05/01/2022 through 02/28 /2023 identified weekly maintenance had not been documented as performed between: (a) 05/20/2022 and 06/02/2022 (b) 09/23/2022 and 10/07/2022 (c) 10/21/2022 and 11 /04/2022 (d) 01/06/2023 and 01/20/2023 (4) The records were reviewed with the interim laboratory manager and testing person #2. Both stated on who stated on 03/28 /2023 at 03:15 pm the weekly maintenance had not been documented as performed as shown above. SYSMEX CA-660 (1) On 03/28/2023 at 11:00 am, the interim -- 4 of 8 -- laboratory manager stated: (a) The laboratory began using the Sysmex CA-660 analyzer to perform PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing for adults on 04/18/2022; (2) A review of the manufacturer's maintenance log showed the following required weekly maintenance procedure: (a) "Clean Instrument Interior/Exterior" (3) A review of maintenance logs from 05/01/2022 through 02/28/2023 identified weekly maintenance had not been documented as performed between: (a) 09/23/2022 and 10/07/2022 (b) 12/23/2022 - 01/06/2023 (4) The records were reviewed with testing person #2 who stated on 03/28/2023 at 11:55 am the weekly maintenance had not been documented as performed as shown above. ORTHO VITROS 350 (1) On 03/28/2023 at 01:05 pm, the interim laboratory manager stated the laboratory performed Albumin, Alkaline Phosphatase, ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), Amylase, Direct Bilirubin, Ethanol, Total Bilirubin, BUN, Calcium, Chloride, Total Cholesterol, CO2, CK (Creatine Kinase), Creatinine, Glucose, HDL Cholesterol, Lactic Acid, Lipase, magnesium, Phosphorus, Total Protein, Sodium, Triglyceride, Acetaminophen, Digoxin, Salicylate, and Uric Acid testing using the Ortho Vitros 350 analyzer; (2) A review of the manufacturer's maintenance log showed the following required weekly maintenance procedures: (a) Clean Tray Platform and Transport Arm (b) Clean Cup Retainer (c) Clean Diluent Bottles (d) Clean Tip Locator Assembly (e) Clean Control Unit Screen (f) Clean Keypad Cover (g) Inspect, Clean, and/or Replace Air Filter (h) Back up QC/Config/Calibration Data (3) A review of maintenance logs from 05/01/2022 through 02/28/2023 identified the weekly maintenance procedures had not been documented as performed as follows: (a) Although checkmarks had been documented on the maintenance log to indicate the weekly maintenance had been performed, there were no dates to prove when it had been performed, therefore, it could not be determined if the procedures had been performed on a weekly basis between 06/24/2022 and 09/02/2022; (b) Although checkmarks had been documented on the maintenance log to indicate the weekly maintenance had been performed, there were no dates to prove when it had been performed, therefore, it could not be determined if the procedures had been performed on a weekly basis between 10/21 /2022 through the end of the review period. (4) The records were reviewed with the interim laboratory manager and testing person #2. Both stated on 03/28/2023 at 03:50 pm there were no records to prove the weekly maintenance had been performed as shown above. 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 -- 5 of 8 -- 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 a review of records and interview with the interim laboratory manager and testing person #2, the laboratory failed to perform calibration verification procedures at least once every six months for one of two test systems. Findings include: (1) On 03 /27/2023 at 02:15 pm, the interim laboratory manager stated the laboratory performed D-dimer testing using the Biosite Triage Meter Pro analyzer; (2) On 03/28/2023 a review of records from August 2021 through the current date identified no evidence calibration verification had been performed at least once every six months during the review period; (3) The records were reviewed with testing person #2 who stated on 03 /28/2023 at 10:00 am, calibration verification procedures had not been performed every six months. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of one patient report and interview with the interim laboratory manager and testing person #2, the laboratory failed to make appropriate reference ranges available for two of two reagent lot numbers implemented for PT (Prothrombin Time) and PTT (Partial Thromboplastin Time) testing. Findings include: (1) On 03/28 /2023 at 11:00 am, the interim laboratory manager stated: (a) The laboratory began using the Sysmex CA-660 analyzer to perform PT/INR (Prothrombin Time /International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing for adults on 04/18/2022; (b) The following reagent lot numbers were put into use on 04 /18/2022: (i) PT - Innovin reagent, lot #564605 (ii) PTT - Actin FSL reagent, lot #562683 (2) A review of the implementation records identified the following: (a) PT - The normal reference interval had been verified as 9.40-11.50 (b) PTT - The normal reference interval had been verified as 23.5-31.3 (3) A review of a patient report with PT and PTT testing performed on 02/21/2023 at 11:18 am showed the following normal ranges: (a) PT - 10.8-14.0 (b) PTT - 19.0-34.0 (4) The reports and implementation records were reviewed with the interim laboratory manager and testing person #2. Both stated on 03/29/2023 at 10:20 am, the laboratory had not updated the normal reference ranges into the laboratory's computer information system D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. -- 6 of 8 -- This CONDITION is not met as evidenced by: Based on a review of records and interview with the interim laboratory manager, the technical consultant failed to provide technical supervision in accordance with 493.1413 of this subpart. Findings include: (1) The technical consultant failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications. Refer to D6035; (2) The technical consultant failed to ensure personnel performing moderate complexity testing had been evaluated at least annually for one of four persons. Refer to D6054. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on a review of records and interview with the interim laboratory manager, the laboratory failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications for two of four competency evaluations and one of three chemistry core proficiency testing attestation forms. Findings include: COMPETENCY EVALUATIONS (1) On 03/27/2023 a review of records for four persons performing moderate complexity testing during -- 7 of 8 -- 2021 and to date in 2023 identified the following for two of four testing persons: (a) Testing Person #3 - The 08/11/2022 evaluation had been performed by an individual who did not meet the regulatory requirements of a technical consultant; (b) Testing Person #5 - The 03/06/2023 evaluation had been performed by an individual who did not meet the regulatory requirements of a technical consultant. (2) The records were reviewed with the interim manager who stated on 03/27/2023 at 02:04 pm, the evaluations had been performed by an individual who did not meet the qualifications of a technical consultant. PROFICIENCY TESTING ATTESTATIONS (1) On 03/27 /2023 a review of 2022 chemistry core proficiency testing records identified one of three attestation statements (third 2022 event) had been signed by an individual who did not meet the minimal educational qualifications of a technical consultant or designee; (2) The records were reviewed with the interim laboratory manager who stated on 03/27/2023 at 03:09 pm, the attestation statement had been signed and dated by an individual who did not meet the regulatory qualification requirements of a technical consultant or designee. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of records and interview with the interim laboratory manager, the technical consultant failed to ensure personnel performing moderate complexity testing had been evaluated at least annually for one of four persons. Findings include: (1) On 03/27/2023 a review of personnel records for four persons performing moderate complexity testing during 2020 and to date in 2023 identified no evidence an annual competency evaluation had been performed for one of four testing persons as follows: (a) Testing Person #3 - Between 09/30/2020 and 06/29/2022 (2) The records were reviewed with the interim manager who stated on 03/27/2023 at 02:04 pm, the annual evaluation had not been performed. -- 8 of 8 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions of Participation: 493.803; D2016: Successful Participation 493.1407; D6000: Laboratory Director, Moderate Complexity 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 a desk review of proficiency testing scores obtained from the Casper 0155D report and proficiency testing Comparative Evaluation obtained from American Proficiency Institute for the third 2021 event, first 2022 event, and second 2022 event, 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 -- the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for Total Bilirubin and two of three consecutive testing events for pCO2 Blood Gas. Refer to 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 a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluation obtained from American Proficiency Institute, the the laboratory failed to achieve satisfactory performance for the analyte Total Bilirubin in two consecutive events and the analyte pCO2 Blood gas in two of three consecutive testing events. Findings include: (1) Total Bilirubin - The laboratory received a score of 60% on the first 2022 event and a score of 60% on the second 2022 event; (2) pCO2 Blood Gas - The laboratory received a score of 60% on the third 2021 event and a score of 60% on the second 2022 event. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte Total Bilirubin in two consecutive events and the analyte pCO2 Blood Gas in two of three consecutive testing events. The laboratory failed to achieve a passing score of 80% for the first 2022 event and second 2022 event for Total Bilirubin; and the third 2021 event and second 2022 event for pCO2 Blood Gas. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte Total Bilirubin in two consecutive events and the analyte pCO2 Blood Gas in two of three consecutive testing events. The laboratory failed to achieve a passing score of 80% for the first 2022 event and second 2022 event for Total Bilirubin; and the third 2021 event and second 2022 event for pCO2 Blood Gas. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/28,29,30,2021. The laboratory was found out of compliance with the following CLIA regulations: 493.1210; D5016: Routine Chemistry 493.1215; D5024: Hematology 493.1403; D6000: Laboratory Director, Moderate Complexity Testing The findings were reviewed with the laboratory manager and lead technologist at the conclusion of the survey. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager and lead technologist, the laboratory failed to ensure the requirements were met for the subspecialty of Routine Chemistry for Blood Gas and ALT testing. Findings include: (1) The laboratory failed to demonstrate the performance specifications for Blood Gas and ALT-V testing. Refer to D5421; (2) The laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Refer to D5429; (3) The laboratory failed to ensure data supported the QC frequency as defined in the QCP portion of the IQCP for Blood Gas testing. Refer to D5445; (4) The laboratory failed to have an ongoing mechanism for performing analytic quality assessment. Refer to D5791. the laboratory failed to have an ongoing mechanism for performing effective analytic quality assessment. Refer to D5791. D5024 HEMATOLOGY CFR(s): 493.1215 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records, written procedure, manufacturer's instructions, and interview with the laboratory manager and lead technologist, the laboratory failed to ensure the requirements were met for the specialty of Hematology for D-dimer and ESR testing. Findings include: (1) The laboratory failed to ensure the demonstrated reportable ranges were utilized for new D-dimer and ESR (Erythrocyte Sedimentation Rate) test methods. Refer to D5421; (2) The laboratory failed to follow the manufacturer's quality control specifications for 4 of 4 ESR control lot numbers. Refer to D5479; (3) The laboratory failed to perform two levels of quality control materials each eight hours of D-dimer testing 26 of 30 days of patient testing. Refer to D5545; (4) The laboratory failed to have an ongoing mechanism for performing effective analytic quality assessment. Refer to D5791. 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 a review of records, observation, and interview with the laboratory manager and lead technologist, the laboratory failed to ensure materials were being stored as required. Findings include: (1) On 04/28/2021 at 04:45 pm, the surveyor observed the outpatient phlebotomy room, located across the hall from the laboratory. The following examples of collection tubes, used by the laboratory to collect patient blood specimens, were observed in the room, with the manufacturer's storage requirements: (a) BD Vacutainer Buff Na Citrate 3.2% tubes - 30 tubes of lot #0227240; storage requirement of 4-25 degrees Centigrade (C); (b) BD Vacutainer Lithium Heparin tubes - 26 tubes of lot #0289731; storage requirement of 4-25 degrees C; (c) BD Vacutainer K2 EDTA tubes - 28 tubes of lot #0316361; storage requirement of 4-25 degrees C. (2) The surveyors asked the laboratory manager and lead technologist if the temperature of the phlebotomy room was being monitored. The laboratory manager and lead technologist stated on 04/28/2021 at 04:55 pm, the laboratory was not monitoring the temperature of the outpatient phlebotomy room. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) -- 2 of 11 -- (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records, written procedure, and interview with the laboratory manager and lead technologist, the laboratory failed to ensure the demonstrated reportable ranges were utilized for 2 of 4 new test methods; and failed to verify the performance specifications for 2 of 4 new test methods. Findings include: QUIDEL TRIAGE METER PRO (1) On 04/28/2021 at 10:30 am, the laboratory manager stated to the surveyor, the laboratory began using the Quidel Triage Meter Pro analyzer to perform D-dimer testing 02/17/2021; (2) The surveyor reviewed the performance specification records for test system and identified the laboratory had demonstrated a reportable range of 198-4030 ng/ml; (3) The surveyor reviewed the records with the laboratory manager and lead technologist and requested documentation to ensure the laboratory was utilizing the reportable range that had been demonstrated by the laboratory. The laboratory manager and lead technologist provided the written procedure for D-dimer testing, which included the manufacturer's reportable range of 100-5000 ng/ml instead of the reportable range of 198-4030 that had been demonstrated by the laboratory; (4) The surveyor reviewed the findings with the lead technologist who stated on 04/28/2021 at 04:00 pm, the laboratory was not using the reportable ranges that had been demonstrated by the laboratory; (5) Refer to D5545 for examples of patient testing performed. MINII-SED ANALYZER (1) On 04/28 /2021 at 10:20 am, the laboratory manager stated to the surveyor, the laboratory began using the minii-Sed analyzer to perform ESR (Erthrocyte Sedimentation Rate) testing 01/11/2021; (2) The surveyor reviewed the performance specification records for test system and identified the laboratory had demonstrated a reportable range of 4.0-97.0 mm/hour; (3) The surveyor then reviewed patient testing records and identified that ESR results less than 4.0 (the lowest value demonstrated by the laboratory) had been reported for 4 of 12 records reviewed: (a) Patient Sample #638657974 - Reported as 1 mm/hour on 02/18/2021 (b) Patient Sample #639694524 - Reported as 1 mm/hour on 03/16/2021 (c) Patient Sample #639793184 - Reported as 1 mm/hour on 03/18/2021 (d) Patient Sample #640041570 - Reported as 1 mm/hour on 03/24/2021 (4) The surveyor reviewed the records with the lead technologist who stated on 04/28/2021 at 11:45, the laboratory was not utilizing the reportable range that had been demonstrated by the laboratory. ISTAT 1 AND EG7+ CARTRIDGE (1) On 04/28 /2021 at 10:30 am, the laboratory manager stated to the surveyor the laboratory began using the iSTAT 1 and the EG7+ Cartridge to perform patient Blood Gas (pH, pCO2, and pO2) testing on 02/14/2020; (2) On 04/29/2021, the surveyor requested the performance specification records to ensure the laboratory demonstrated the accuracy, precision, reportable range, and verified the reference ranges for the new test system prior to putting into use for patient testing. The lead technologist stated to the surveyor on 04/28/2021 at 03:30 pm, the laboratory did not verify the performance specifications for the EG7+ cartridge; (3) Refer to D5445 for examples of patient Blood Gas testing performed when the laboratory failed to verify the performance specifications for the new test system. ALT-V REAGENT (1) On 04/28/2021 at 10:30 am, the laboratory manager stated the following to the surveyor: (a) The laboratory performed ALT (Alanine Aminotransferase) testing, which was included as part of a CMP (Comprehensive Metabolic Panel) using the Ortho Vitros 350 analyzer; (b) ALT- V (a new ALT reagent), was put into use on 08/22/2019. (2) On 04/30/2021, the surveyor requested the performance specification records for ALT-V to ensure the laboratory demonstrated the accuracy, precision, reportable range, and verified the -- 3 of 11 -- reference range for the new test prior to putting into use for patient testing. The laboratory manager and lead technologist stated to the surveyor on 04/30/2021 at 09: 40 am, the laboratory did not verify the performance specifications for ALT-V; (3) The following were examples of patient CMP testing performed, which included the analyte ALT, when the laboratory failed to verify the performance specifications for the new test: (a) Patient Sample #618784287 - Testing performed on 08/27/2019 (b) Patient Sample #618929575 - Testing performed on 08/31/2019 (c) Patient Sample #622602845 - Testing performed on 12/12/2019 (d) Patient Sample #622988173 - Testing performed on 12/23/2019 (e) Patient Sample #625714440 - Testing performed on 03/06/2020 (f) Patient Sample #62633778 - Testing performed on 03/20/2020 (g) Patient Sample #628834280 - Testing performed on 06/18/2020 (h) Patient Sample #62970429 - Testing performed on 06/30/2020 (i) Patient Sample #63959526 - Testing performed on 03/09/2021 (j) Patient Sample #63945319 - Testing performed on 03/17/2021 (k) Patient Sample #640325287 - Testing performed on 03/31/2021 D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Findings include: (1) On 04/28/2021 at 10:30 am, the laboratory manager stated to the surveyor the laboratory performed Albumin, Alkaline Phosphatase, ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), Amylase, Direct Bilirubin, Total Bilirubin, Calcium, Chloride, Total Cholesterol, HDL ((High Density Lipoprotein), CO2, CK (Creatine Kinase), Creatinine, Glucose, Lactic Acid, Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total Protein Triglycerides, BUN, Uric Acid, Acetaminophen, Alcohol, Salicylates, and Digoxin testing using the Ortho Vitros 350 analyzer; (2) On 04/29 /2021, the surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance log for the analyzer, which required the following weekly maintenance: (a) Clean Tray Platform and Transport Arm (b) Clean Cup Retainer (c) Clean Diluent Bottles (d) Clean Tip Locator Assembly (e) Clean Control Unit Screen (f) Clean Keypad Cover (g) Inspect, Clean, and/or Replace Air Filter (h) Back up QC/Config/Calibration Data (3) The surveyor then reviewed maintenance records for 15 months (January 2020 through March 2021). The weekly maintenance had not been documented as performed between: (a) 04/10/2020 and 04/24/2020 (b) 10/23/2020 and 11/06/2020 (4) The surveyor reviewed the records with the laboratory manager who stated on 04/29/2021 at 04:50 pm, the maintenance had not been performed as stated above. 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 -- 4 of 11 -- 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 review of records and interview with the laboratory manager and lead technologist, the laboratory failed to ensure data supported the QC frequency as defined in the QCP portion of the IQCP. Findings include: (1) On 04/28/2021 at 10:30 am, the laboratory manager stated the following to the surveyor: (a) The laboratory began using the iSTAT 1 and the EG7+ Cartridge to perform patient Blood Gas (pH, pCO2, and pO2) testing on 02/14/2020; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) On 04/29/2021, the surveyor reviewed the IQCP (dated as effective on 02/01/2020) and identified the QCP (Quality Control Plan) required two levels of external QC (Quality Control) materials be performed every 30 days and with new lot numbers or shipments of test cartridges; (3) The surveyor then reviewed the supporting documentation for the QCP and identified the following: (a) The laboratory had not tested external QC materials to support the QC frequency of every 30 days, as defined in the QCP; (b) Two levels of QC had been tested for 9 days (not at least 30 days). (4) The surveyor reviewed the records with the laboratory manager and lead technologist and asked if additional documentation was available to support the reduced external QC frequency of every 30 days. The laboratory manager and lead technologist stated to the surveyor on 04/29 /2021 at 03:45 pm, QC had not been tested for at least 30 days; (5) The following were examples of patient Blood Gas testing performed: (a) Patient Sample #624927802 - Testing performed on 02/14/2020 (b) Patient Sample #625361211 - Testing performed on 02/26/2020 (c) Patient Sample #625714524 - Testing performed on 03/06/2020 (d) Patient Sample #626332334 - Testing performed on 03/24/2020 (e) Patient Sample #626553832 - Testing performed on 04/02/2020 (f) Patient Sample #628479648 - Testing performed on 06/09/2020 (g) Patient Sample #628967114 - Testing performed on 06/23/2020 (h) Patient Sample #629524974 - Testing performed on 07/07/2020 (i) Patient Sample #630455458 - Testing performed on 07/30/2020 (j) Patient Sample #630890794 - Testing performed on 08/11/2020 (k) Patient Sample #631197584 - Testing performed on 08/18/2020 (l) Patient Sample #631945364 - Testing performed on 09/06/2020 (m) Patient Sample #632740412 - Testing performed on 09/25/2020 (n) Patient Sample #633895269 - Testing performed on 10 /23/2020 (o) Patient Sample #634178803 - Testing performed on 10/30/2020 (p) Patient Sample #634421398 - Testing performed on 11/05/2020 (q) Patient Sample #634727254 - Testing performed on 11/12/2020 (r) Patient Sample #635427328 - Testing performed on 11/30/2020 (s) Patient Sample #638330154 - Testing performed on 02/09/2021 (t) Patient Sample #638650379 - Testing performed on 02/18/2021 (u) Patient Sample #639290160 - Testing performed on 03/05/2021 (v) Patient Sample #639671628 - Testing performed on 03/15/2021 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. -- 5 of 11 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and the lead technologist, the laboratory failed to perform control procedures each day of blood bank testing for 1 of 10 days of patient testing. Findings include: (1) On 04/28/2021 at 10:00 am, the laboratory manager stated to the surveyor the laboratory performed Crossmatch Testing, which consisted of ABO/Rh, Antibody Screen, and Compatibility testing (performed between the patient and red blood cell donor unit(s)) using the tube method; (2) The surveyor reviewed records for blood bank testing performed from 01/02/2020 and 04/12/2021 and identified quality control had not been performed for 1 of 10 days when a patient Type and Screen had been performed. The specific day was 09/25/2020; (3) The surveyor reviewed the records with the lead technologist who stated on 04/28/2021 at 03:10 pm, quality control had not been documented as performed on 09/25/2020. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager and lead technologist, the laboratory failed to follow the manufacturer's quality control specifications for 4 of 4 lot numbers. Findings include: (1) On 04/28/2021, the laboratory manager stated the following to the surveyor: (a) The laboratory began using the minii-Sed analyzer to perform ESR (Erthrocyte Sedimentation Rate) testing 01/11/2021; (b) The Seditrol Erythrocyte Sedimentation Rate control materials (level 1 and level 2) were performed each day of patient testing. (2) On 04/29/2021, the surveyor reviewed the manufacturer's instructions for the control materials. They stated "It is recommended that each laboratory establish its own means and acceptable ranges and use those provided only as a guide; (3) The surveyor then reviewed QC (Quality Control) records for 4 lot number of control materials used from 01/11/2021 through 04/29/2021. The records showed the laboratory had used the package insert means and limits or established a mean and used the manufacturer's limits for each level of control instead of establishing their own means and limits as stated in the manufacturer's package insert: (a) Controls in use from 01/11/2021 through 03/31/2021: (i) Level 1 lot #C138 - The laboratory had used the manufacturer's range of 6-18 mm/hour; (ii) Level 2 lot #C238 - The laboratory had used the manufacturer's range of 40-94 mm/hour. (b) Controls put into use on 04/01/2021 and were currently in use: (i) Level 1 lot #C139 - The laboratory had established a mean of 8.0 (manufacturer's mean was 10), but used the manufacturer's limits of acceptability, resulting in a range of 1-15 mm/hour (manufacturer's range was 3-17 mm/hour); (ii) Level 2 lot #C239 - The laboratory had used the manufacturer's range of 37-89 mm/hour. (4) The surveyor reviewed the findings with the lead technologist, who stated to the surveyor on 04/29/2021 at 11:30 am, the laboratory had not followed the manufacturer's instructions for establishing means and limits of acceptability for the controls; (5) The following were examples of patient ESR testing performed: (a) Patient Sample #6379652091 - Testing performed -- 6 of 11 -- on 02/01/2021 (b) Patient Sample #638565813 - Testing performed on 02/16/2021 (c) Patient Sample #638876388 - Testing performed on 02/24/2021 (d) Patient Sample #639195481 - Testing performed on 03/03/2021 (e) Patient Sample #639703392 - Testing performed on 03/16/2021 (f) Patient Sample #640826737 - Testing performed on 04/13/2021 (g) Patient Sample #641053114 - Testing performed on 04/19/2021 (h) Patient Sample #641258927 - Testing performed on 04/23/2021 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 a review of records and interview with the laboratory manager and lead technologist, the laboratory failed to perform two levels of quality control materials each eight hours of D-dimer testing 26 of 30 days of patient testing. Findings include: (1) On 04/28/2021 at 10:30 am, the laboratory manager stated to the following to the surveyor: (a) The laboratory began using the Quidel Triage Meter Pro analyzer to perform D-dimer testing 02/17/2021; (b) Two levels of QC (Quality Control) materials were performed every 30 days and with new lot numbers of test devices. (2) The surveyor asked the lead technologist if an IQCP (Individualized Quality Control Plan) had been developed for the test system. The lead technologist stated on 04/28 /2021 at 04:30 pm, an IQCP had not been developed. Therefore, the surveyor determined two levels of QC materials must be performed each eight hours of patient testing; (3) The surveyor reviewed QC and patient testing records for testing performed from 02/17/2021 through 04/28/2021. The records showed two levels of QC materials had not been performed each eight hours of patient D-dimer testing for 26 of 30 days of patient testing reviewed. Two levels of QC materials had not been performed for the following days when D-dimer testing had been performed: (a) Patient Sample #638611530 - Testing performed on 02/17/2021 (b) Patient Sample #638642874 - Testing performed on 02/18/2021 (c) Patient Sample #638698297 - Testing performed on 02/19/2021 (d) Patient Sample #638847767 - Testing performed on 02/23/2021 (e) Patient Sample #638962906 - Testing performed on 02/26/2021 (f) Patient Sample #639041606 - Testing performed on 02/28/2021 (g) Patient Sample #63090350 - Testing performed on 03/01/2021 (h) Patient Sample #639120872 - Testing performed on 03/02/2021 (i) Patient Sample #639319173 - Testing performed on 03/06/2021 (j) Patient Sample #639332400 - Testing performed on 03/07/2021 (k) Patient Sample #639458576 - Testing performed on 03/10/2021 (l) Patient Sample #639529520 - Testing performed on 03/11/2021 (m) Patient Sample #639560820 - Testing performed on 03/12/2021 (n) Patient Sample #639630279 - Testing performed on 03/14/2021 (o) Patient Sample #639657331 - Testing performed on 03/15/2021 (p) Patient Sample #639817234 - Testing performed on 03/18/2021 (q) Patient Sample #639884768 - Testing performed on 03/20/2021 (r) Patient Sample #640185825 - Testing performed on 03/28/2021 (s) Patient Sample #640325546 - Testing performed on 03/30/2021 (t) Patient Sample #640437074 - Testing performed on 04/03/2021 (u) Patient Sample #640508292 - Testing performed on 04/05/2021 (v) Patient Sample #640694673 - Testing performed on 04/09/2021 (w) Patient Sample #640918461 - Testing performed on 04/15/2021 (x) Patient Sample #641124257 - Testing performed on 04/20/2021 (y) Patient Sample #641344995 - Testing performed on 04/26/2021 (z) -- 7 of 11 -- Patient Sample #641438860 - Testing performed on 04/28/2021 (4) The surveyor reviewed the records with the laboratory manager and lead technologist. Both stated on 04/28/2021 at 04:45 pm, two levels of QC materials had not been performed each eight hours of patient testing. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to ensure units of blood were stored under appropriate conditions for 3 of 26 temperature charts. Findings include: (1) On 04/28/2021 at 11:00 am, the laboratory manager stated to the surveyor units of packed red blood cells were stored in the blood bank refrigerator. The units were to be used for patient transfusions; (2) On 04/28/2021 at 11:30 am, the surveyor observed the thermograph temperature recorder for the blood bank refrigerator. The refrigerator had a recorder connected to it for continuously recording the temperature on thermograph charts (Note: units of packed cells must be stored at 1-6 degrees Centigrade). Each chart monitored the temperature for a 7 day period; (3) The surveyor reviewed 26 refrigerator charts dated from 10/16/2020 through 04/23/2021. The review showed that 3 of 26 charts had not been changed by the 7th day of as follows: (a) Chart #1 - The chart was put into use on 10/23/2020 and removed on 11/02/2020 (10 days); (b) Chart #2 - The chart was put into use on 12/18/2020 and removed on 12/28/2020 (10 days); (c) Chart #3 - The chart was put into use on 04/09/2021 and removed on 04/23/2021 (14 days). (4) The surveyor reviewed the charts with the laboratory manager who stated on 04/28/2021 at 01:30 pm, the charts had not been changed by the 7th day, as stated above. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records, written procedure, manufacturer's instructions, observation, and interview with the laboratory manager and lead technologist, the laboratory failed to have an ongoing mechanism for performing effective analytic quality assessment. Findings include: (1) It was determined the laboratory did not have an effective mechanism for performing analytic quality assessment because of the following issues identified during the survey: (a) The laboratory failed to ensure materials were being stored as required. Refer to D5413; (b) The laboratory failed to ensure the demonstrated reportable ranges were utilized for 2 of 4 new test methods; -- 8 of 11 -- and failed to verify the performance specifications for 2 of 4 new test methods. Refer to D5421; (c) The laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Refer to D5429; (d) The laboratory failed to ensure data supported the QC frequency as defined in the QCP portion of the IQCP. Refer to D5445; (e) The laboratory failed to perform control procedures each day of blood bank testing for 1 of 10 days of patient testing. Refer to D5449; (f) The laboratory failed to follow the manufacturer's quality control specifications for 4 of 4 lot numbers. Refer to D5479; (g) The laboratory failed to perform two levels of quality control materials each eight hours of D-dimer testing 26 of 30 days of patient testing. Refer to D5545; (h) The laboratory failed to ensure units of blood were stored under appropriate conditions for 3 of 26 temperature charts. Refer to D5555. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records, manufacturer's instructions, written procedure, and interview with the laboratory manager and lead technologist, the laboratory director failed to provide overall management and direction for moderate complexity testing. Findings include: (1) The laboratory director failed to ensure verification procedures for new test systems were adequate to determine the performance characteristics. Refer to D6013; (2) The laboratory director failed to ensure a quality control program was maintained to ensure the quality of laboratory services. Refer to D6020; (3) The laboratory director failed to ensure a quality assessment program had been established and maintained. Refer to D6021. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a review of records, written procedure, and interview with the laboratory manager and lead technologist, the laboratory director failed to ensure verification procedures for new test systems were adequate to determine the performance characteristics. Findings include: (1) The laboratory director failed to ensure the demonstrated reportable ranges were utilized for 2 of 4 new test methods; and failed to verify the performance specifications for 2 of 4 new test methods. Refer to D5421. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) -- 9 of 11 -- The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager and lead technologist, the laboratory director failed to ensure a quality control program was maintained to ensure the quality of laboratory services. Findings include: (1) The laboratory director failed to ensure data supported the QC frequency as defined in the QCP portion of the IQCP. Refer to D5445; (2) The laboratory director failed to ensure the manufacturer's quality control specifications had been followed for 4 of 4 lot numbers. Refer to D5479; (3) The laboratory director failed to ensure two levels of quality control materials had been performed each eight hours of D-dimer testing 26 of 30 days of patient testing. Refer to D5545. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, written procedure, and interview with the laboratory manager and lead technologist, the laboratory director failed to ensure a quality assessment program had been established and maintained. Findings include: (1) The laboratory director failed to ensure the laboratory had an ongoing mechanism for performing effective analytic quality assessment. Refer to D5791. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the technical consultant failed to evaluate personnel performing moderate complexity testing at least annually for 2 of 6 persons. Findings include: (1) On 04/28/2021, the surveyor reviewed personnel records for 6 persons who performed moderate complexity testing during 2019, 2020, and to date in 2021. For 2 of the 6 persons (testing person #3 and -- 10 of 11 -- testing person #5), there was no evidence annual evaluations had been performed as follows: (a) Testing Person #3 - Between 10/25/2019 and 03/26/2021 (b) Testing Person #5 - Between 09/05/2018 and 10/21/2020 (2) The surveyor reviewed the findings with the laboratory manager who stated on 04/28/2021 at 12:15 pm, the annual evaluations had not been performed as indicated above. -- 11 of 11 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. 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 a desk review of proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two of three testing events for the analyte ALT (Alanine Aminotransferase). Refer to D2094 and D2096. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to achieve a successful performance for the analyte ALT (Alanine Aminotransferase). Findings include: (1) The laboratory failed to achieve satisfactory performance on the third 2019 event and first 2020 events. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/14/19 through 01/16/19. The findings were reviewed with the laboratory director, laboratory supervisor, and hospital administrator during an exit conference performed at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulation: 493.1409; D6033: Technical Consultant D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with laboratory supervisor, the laboratory failed to follow their written general supervisor competency policy based on the position responsibilities as listed in Subpart M. Findings include: (1) On the second day of the survey, the surveyor reviewed the policy titled, "Reapportion of Laboratory Director responsibilities to Other Personnel" which stated, "The Laboratory Director will evaluate and document competency of the General Supervisor at least once annually"; (2) The surveyor then reviewed personnel records for competency assessments performed during 2017 and 2018. There was no evidence the general supervisor competencies, based on their job responsibilities, had been performed; (3) The surveyor asked the laboratory supervisor if there was documentation to substantiate competencies had been performed for the general supervisor based on job responsibilities in 2017 and 2018. The laboratory supervisor stated the general supervisor competencies, based on job responsibilities, had not been performed. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to review and evaluate proficiency testing results. Findings include: (1) On the first day of the survey, the surveyor reviewed the 2017 and 2018 proficiency testing records. The following biases were identified (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) First 2018 Hematology Event (i) Platelet - 3 of 5 results exhibited a positive bias (aa) Sample XE-02 - SDI of 3.0 (bb) Sample XE-03 - SDI of 2.5 (cc) Sample XE-04 - SDI of 3.3 (2) The surveyor could not locate evidence in the records proving the biases had been identified and addressed; (3) The records were reviewed with the laboratory supervisor who stated the biases had not been addressed. NOTE: D5211 was cited on the recertification survey performed on 05/10,11,12/17. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to evaluate the accuracy of testing when a proficiency result had not been graded by the proficiency program. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017 and 2018 proficiency testing records and identified the following had not been evaluated by the proficiency testing program: (a) Chemistry Core (i) 2017 third event (aa) CK-MB sample CH-15 (ii) 2018 third event (aa) CK-MB samples CH-11, CH-12, CH-13, CH-14 and CH-15 (b) Hematology /Coagulation (i) 2018 first event (aa) BCI (Blood Cell Identification) sample BCI-01 (bb) PT (Prothrombine Time) sample HCP-05 (cc) PTT (Partial Thromboplastin Time) sample HCA-03 (2) The surveyor further reviewed the records and could not locate documentation verifying the laboratory had performed a self-evaluation of the non-graded results; (3) The surveyor asked the laboratory supervisor if the results had been documented as evaluated. The laboratory supervisor reviewed the records and stated the non-graded results had not been documented as reviewed. NOTE: D5215 was cited on the recertification survey performed on 05/10,11,12/17 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. -- 2 of 7 -- This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with the laboratory supervisor, the laboratory failed to follow their written policy for emergency issue of blood. Findings include: (1) On the first day of the survey, the laboratory supervisor stated to the surveyor ABO/Rh, Antibody Screen, and Compatibility testing were performed using the tube method; (2) The surveyor reviewed the policy titled "EMERGENCY ISSUE OF BLOOD FOR TRANSFUSION", which stated, "Routine compatibility testing will be completed promptly. If incompatibility is found, the physician will be alerted immediately by the Blood Bank technician"; (3) The surveyor then reviewed 2018 emergency issue of blood for transfusion and identified the following: (a) Routine compatibility testing had not been documented as performed for the following: (i) O Negative unit (W200218573396) issued on 12/16 /18; (4) The surveyor reviewed the findings with the laboratory supervisor, who stated compatibility testing had not been performed for the unit as required by policy. NOTE: 5401 was cited on the recertification survey performed on 05/10,11,12/17 D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory supervisor, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Findings include: (1) On the first day of the survey, the laboratory supervisor stated to the surveyor routine chemistry testing was performed on the Ortho Vitros 350 analyzer; (2) On the second day of the survey, the surveyor reviewed the manufacturer's maintenance requirements, as stated on the manufacturer's maintenance logs. The requirements for weekly maintenance were as follows: (a) Clean tray platform and transport arm (b) Clean cup retainer (c) Clean diluent bottles (d) Clean tip locator assembly (d) Clean control unit screen (e) Clean keypad cover (f) Inspect, clean and/or replace air filter (3) The surveyor then reviewed maintenance records between January 2018 through the second day of the survey. The following was identified: (a) There was no evidence the weekly maintenance had been performed: (i) Between 12/14/18 and 01/14/19 (4) The surveyor reviewed the records with the laboratory supervisor, who stated the maintenance records were not available to demonstrate maintenance had been performed as required. NOTE: D5429 was cited on the recertification survey performed on 05/10,11,12/17 D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or -- 3 of 7 -- baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with the laboratory supervisor, the laboratory failed to follow their written protocol for ensuring the urine centrifuge was functioning properly. Findings include: (1) On the first day of the survey, the laboratory supervisor stated to the surveyor urine sediment examinations were performed in the laboratory. The specimens were processed in the Damon IEC Sorvall Easyspin centrifuge at a speed of 1800 rpm (revolutions per minute) for 5 minutes; (2) The surveyor reviewed the policy titled "CENTRIFUGE AND PERFORMANCE CHECKS". It stated "Centrifuges will be checked routinely at least once annually for proper performance. Performance checks shall also be done when the equipment is accidentally dropped, moved to another environment or when test results do not yield expected results."; (3) The surveyor reviewed the centrifuge maintenance records for 2017 and 2018: (a) The speed and time were checked on the following dates: (i) 11/09/17 - 3305 rpm for 5 minutes (ii) 11/28/18 - 3309 rpm for 5 minutes (b) There was no evidence the centrifuge speed had been checked at 1800 rpm (the speed used to process urine specimens) during 2017 and 2018; (4) The surveyor reviewed the findings with the laboratory supervisor, who stated the centrifuge speed had not been checked at the speed used to process urine specimens. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to have control procedures that monitored the accuracy of the analytic process. Findings include: (1) On the third day of the survey, the laboratory supervisor stated the following to the surveyor: (a) CK (Creatine Kinase) testing was performed using the Ortho Vitros 350 analyzer; (b) Two levels of Ortho Vitros control materials were performed each day of patient testing. (2) The surveyor reviewed quality control records for testing performed between 11/25/18 through 01/13/19. The following bias (the control results were consistently below the established mean) were identified as follows: (a) CK level 2 (lot# C6274 - put into use on 10/18/18) - 47 out of 48 control results were below the mean. (3) There was no evidence in the records the control bias had been identified and addressed; (4) The surveyor reviewed the records with the laboratory supervisor and asked if there was documentation to prove the bias had been identified and addressed. The laboratory supervisor stated the bias had not been addressed; (5) Since the above bias had not been identified and -- 4 of 7 -- addressed, the surveyor determined the laboratory failed to have control procedures that monitored the accuracy of testing for the above analyte. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to ensure reference intervals were determined as appropriate for the laboratory's patient population. Findings include: (1) On the first day of the survey, the laboratory supervisor stated to the surveyor CBC (Complete Blood Count) testing was performed using the Sysmex 1000i analyzer; (2) On the third day of the survey, the surveyor reviewed two patient CBC reports - the first report was for an adult female patient with the testing performed on 01/14/19 at 08:29 am; the second report was for an adult male patient with the testing performed on 08/16/18 at 02:05 pm. Both reports included the same reference intervals for the CBC parameters of RBC (Red Blood Cell), Hemoglobin, and Hematocrit which were: (a) RBC - 3.80 - 5.10 L (b) Hemoglobin - 11.7 - 15.5 gm/dL (c) Hematocrit - 35 - 45 % (3) The surveyor reviewed the findings with the laboratory supervisor, who stated the patient reports did not include gender specific reference ranges. NOTE: Routinely, female reference intervals for the analytes RBC, Hemoglobin, and Hematocrit are lower than male reference intervals. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017 and 2018 proficiency testing records. It was identified for 5 of 12 events, the attestation statements had been signed approximately 2 - 4 months after the samples had been tested (not within a timeframe for the director to attest that, at the time of testing, the proficiency samples had been tested as required) as follows: (a) Third 2017 Hematology/Coagulation Event - The samples had been tested on 11/28/17 and the attestation statement had not been signed by the laboratory director until 01/09/18; (b) First 2018 Chemistry Core Event - The samples had been tested on 02/06/18 and the attestation statement had not been signed by the laboratory director until 04/10/18; (c) Third 2018 Chemistry Core Event - The samples had been tested on 09/13/18 and -- 5 of 7 -- the attestation statement had not been signed by the laboratory director until 01/05/19; (d) Second 2018 Hematology/Coagulation Event - The samples had been tested on 07 /19/18 and the attestation statement had not been signed by the laboratory director until 09/08/18; (e) Third 2018 Hematology/Coagulation Event - The samples had been tested on 11/27/18 and the attestation statement had not been signed by the laboratory director until 01/05/19. (2) The surveyor reviewed the findings with laboratory supervisor and explained that attestation statements must be signed within a timeframe to definitively attest to the fact that proficiency samples were tested in the same manner as patient specimens. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the technical consultant failed to provide technical oversight in accordance with 493.1413 of this subpart. Findings include: (1) The technical consultant failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be -- 6 of 7 -- acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications. Findings include: (1) On the first day of the survey, the surveyor reviewed records for 4 persons performing moderate complexity testing in 2018. The records indicated the evaluations for 4 of 4 persons had been performed by an individual who did not meet the regulatory qualification requirements of the technical consultant: (a) Testing Person #2 (i) The 10/25/18 evaluation had been performed by the laboratory supervisor (this person had earned an associate degree in applied science). (b) Testing Person #3 (i) The 09/06/18 evaluation had been performed by the laboratory supervisor. (c) Testing Person #4 (i) The 11/16/18 evaluation had been performed by the laboratory supervisor. (d) Testing Person #5 (i) The 11/16/18 evaluation had been performed by the laboratory supervisor. (2) The surveyor explained to the laboratory supervisor that all components of the competency evaluations must be performed by a person who qualifies as a technical consultant (an individual with a minimum of a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution, and at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service). -- 7 of 7 --