City Medical

Summary Statement of Deficiencies D0000 An unannounced revisit survey was performed on February 3, 2025 as a follow-up to the September 16, 2024 recertification survey. The Department of Licensing and Regulatory Affairs has evaluated this facility and determined it is out of compliance with the following conditions: 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to have the date and time of specimen collection on the test request for three (Patients 1, 3, and 4) of four patient test records reviewed. Findings include: 1. A review of three patient test records revealed a lack of time the laboratory received the specimens: a. Patient #1 had their test request placed on 12/31/24 at the Southgate Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- location and test results reported on 1/6/25. b. Patient #3 had their test request placed on 1/13/25 at the Southgate location and test results reported on 1/16/25. c. Patient #4 had their test request placed on 1/17/25 at the Southgate location and test results reported on 1/23/25. 2. An interview on 2/3/25 at 11:33 am with the Technical Consultant and Testing Personnel confirmed the test requests for the patients listed above did not have the date and time of specimen collection. 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) (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 record review and interviews, the laboratory failed to verify the reference intervals for its urine pH testing on the Siemens Viva Pro E analyzer for one (January 2025) of one month since the laboratory started testing urine pH. Findings include: 1. An interview on 2/3/25 at 10:10 am with the Testing Personnel revealed the laboratory started testing patient specimens for urine pH at the beginning of January 2025 using the Siemens Viva Pro E analyzer. 2. A review of the laboratory's verification of performance specification records for its pH test kit with the Siemens Viva Pro E analyzer revealed a lack of verification of reference intervals. 3. An interview on 2/3/25 at 10:29 am with the Technical Consultant confirmed the laboratory had not verified the manufacturer's reference intervals prior to testing patient specimens. 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 record review and interview with the Technical Consultant and Testing Personnel, the laboratory failed to include reference intervals for its urine pH testing on test reports for three (Patients 1, 3, and 4) of four patient test reports reviewed. Findings include: 1. A review of four patient test reports revealed Patients 1, 3, and 4 had urine pH testing performed and no reference intervals were included on the test report for interpretation. 2. An interview on 2/3/25 at 11:33 am with the Technical Consultant and Testing Personnel confirmed reference intervals were not included on the test report. D6012 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(i) -- 2 of 4 -- 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) The test methodologies selected have the capability of providing the quality of results required for patient care; This STANDARD is not met as evidenced by: . Based on record review and interviews, the Laboratory Director failed to ensure verification of the reference intervals was performed and acceptable for its urine pH testing on the Siemens Viva Pro E analyzer. Refer to D5421. D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) 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)(8) Ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant and Testing Personnel, the Laboratory Director failed to ensure reference intervals for its urine pH testing were included on test reports. Refer to D5807. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: . Based on record review and interviews, the Laboratory Director failed to ensure procedures for performing pH testing were approved, signed, and dated by the laboratory director before use. Refer to D5407. D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. -- 3 of 4 -- This STANDARD is not met as evidenced by: . Based on record review and interviews, the Technical Consultant failed to verify the reference intervals for its urine pH testing on the Siemens Viva Pro E analyzer. Refer to D5421. -- 4 of 4 --

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #1 (TC1), the laboratory failed to follow laboratory's rejection policy and manufacturer's instructions for storage and preservation of specimens tested for Cocaine and Norhydrocodone for 8 of 10 (8567, 6786, 3541, 3822, 3249, 3421, 3188, 8065) patient test records reviewed. Findings include: 1. Based on record review of patient reports (8 of 10), the surveyor observed prolonged testing times after specimen collection of patient samples: 1.) Patient 1(8567): Collected 11/27/2023 and tested on 12/05/2023 2.) Patient 2 (6786): Collected 06/26/20240 and tested on 7/04/2024 3.) Patient 3 (3541): Collected 09/18/2024 and tested on 09/27/2023 4.) Patient 4(3822): Collected 07/24/2023 and tested on 08/03/2023 5.) Patient 5 (3249): Collected 06/20/2023 and tested on 06/28/2023 6.) Patient 6 (3421): Collected 1/20/2023 and tested on 1/31 /2023 7.) Patient 7(3188) : Collected 12/21/2022 and tested on 01/04/2023 8.) Patient 8 (8065): Collected 03/10/224 and tested on 03/20/2024 2. Review of manufacturer's instructions revealed sample must be frozen if tested beyond 5 days for Cocaine and Norhydrocodone to ensure specimen stability. 3. Interview with TC1 confirmed the that specimens were not rejected per laboratory's policy and not frozen according to manufacturer's instructions. D5313 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 5 -- CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: . . Based on record review and interview with Technical Consultant #1 (TC1) the laboratory failed to ensure the time the laboratory received specimens was documented for 10 of 10 (8567, 6786, 3541, 3822, 3249, 3421, 3188, 8065, 7507, 4813) patient test records reviewed. Findings include: 1. A review of the laboratory's test records revealed a lack of time the laboratory received specimens for the following patients: 1) Patient 1 (8567): Collected 11/27/2023 2) Patient 2 (6786): Collected 06/26/2024 3) Patient 3 (3541): Collected 09/18/2024 4) Patient 4(3822): Collected 07/24/2023 5) Patient 5 (3249): Collected 06/20/2023 6) Patient 6 (3421): Collected 1/20/2023 7) Patient 7 (3188): Collected 12/21/2022 8) Patient 8 (8065): Collected 03/10/2024 9) Patient 9 (7507): Collected 03/03/2023 10) Patient 10 (4813): Collected 09/28/2022 2. An interview with TC1 on 09/16/2024 at 12:20 pm confirmed the laboratory did not document the time the laboratory received specimens. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #1 (TC1) the laboratory failed to ensure the current Laboratory Director (LD) approved, signed and dated laboratory procedures before use. Findings include: 1. Record review of laboratory policies and procedures revealed they were not signed, dated, and approved by the current lab director. 2. Interview with TC1, on 09/16/2024 at 10:50 am confirmed that laboratory policies and procedures were not signed, dated and approved by the current LD. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with Technical Consultant #1, the laboratory failed to ensure proper storage of urine toxicology specimens for two (September 2022 to September 2024) of two years reviewed. Findings include: 1. The surveyor observed the laboratory's freezer on 9/16/24 at 9:13 am with urine specimens inside. 2. A review of the laboratory's "Temperature Log" documentation from -- 2 of 5 -- September 2022 to September 2024 revealed the freezer acceptable temperature range was "less than or equal to -20 degrees C" and all readings were documented as "-12." 3. A review of the laboratory's "Policy and Procedures for Urine Drug Testing at City Medical" revealed a section stating, "A urine aliquot will remain frozen on site for 5 days." 4. A review of the laboratory's "Siemens Cocaine Metabolite Assay" instructions for use revealed a section titled "Specimen Collection and Preparation" stating, "After 7 days unrefrigerated or 30 days refrigerated, samples should be stored frozen (-20 degrees C) for up to 3 years." 5. A review of the laboratory's "Siemens Buprenorphine Assay" instructions for use revealed a section titled "Specimen Collection and Preparation" stating, "If not analyzed immediately, specimens may be stored refrigerated or unrefrigerated up to 5 days. After 5 days specimens should be stored frozen at -20 degrees C." 6. A review of the laboratory's "Siemens Oxycodone Assay" instructions for use revealed a section titled "Specimen Collection and Preparation" stating, "After 7 days specimens should be stored frozen at -20 degrees C." 7. An interview on 9/16/24 at 10:17 am with Technical Consultant #1 confirmed the specimen freezer temperatures were out of range. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on observation, interview, and record review with Testing Consultant #1 (TC1) the laboratory failed to label 2 testing reagents on the Siemens Viva-ProE instrument. Findings include: 1. The surveyor observed on 9/16/2024 at 9:24 am that hydrochloric acid (HCL) reagent and probe cleaner on Siemens Viva-ProE instrument was not labeled with open date or expiration date. 2. An interview with TC1 on 9/16 /2024 at 9:25 am confirmed that reagents on the instrument were not labeled. 3. A review of the "Laboratory's General Laboratory Policies", Section "Reagents, Controls, Test Kits, Media, Etc.," it states, "All reagents, controls, test kits, media, etc. are marked with appropriate, date received, date opened, date initially used, and the expiration date ..." 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 record review and interview with Technical Consultant #1 (TC1), the laboratory failed to ensure the Laboratory Director, performing the duties of a Technical Consultant, met the qualification requirements at 493.1411. Findings -- 3 of 5 -- include: 1. The laboratory failed to ensure the personnel performing the Technical Consultant duty of performing testing personnel competency assessments was qualified. 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 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 record review and interview Technical Consultant #1 (TC1), the laboratory failed to ensure the personnel performing the Technical Consultant duty of performing testing personnel's competency assessments was qualified. Findings include: 1. A review of the laboratory's personnel competency assessment records revealed that Laboratory Director (LD) performed competency assessments in 2024, 2023, and 2022 for TC1. 2. A record review of the Laboratory Director's credentials revealed that the LD was not qualified to perform duties of the Technical Consultant. 3. A review of the laboratory's "Personnel Training and Qualifications" policy revealed a section stating, "Personnel must be evaluated by the technical consultant at least semiannually during the first year of employment. Thereafter, testing personnel are -- 4 of 5 -- evaluated yearly." 4. An interview with TC1 on 09/16/2024 at 10:00 am confirmed LD performed the competency assessments for TC1 and was not qualified to be the laboratory's Technical Consultant. -- 5 of 5 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation and interview with the Technical Consultant (TC), the laboratory failed to ensure specimen collection tubes had not exceeded their expiration dates for 9 blood specimen collection tubes in the laboratory's phlebotomy supply cart. Findings include: 1. The surveyor observed the phlebotomy supply cart in the hallway outside of the laboratory's storage room at 9:37 am on 8/8/22. The following blood collection tubes were found to have exceeded their expiration dates: a. All sodium citrate blue-top tubes i. BD Vacutainer lot number 0316282 expiration date 8/31/21, two tubes total. ii. BD Vacutainer lot number 1259182 expiration date 6 /30/22, two tubes total. iii. BD Vacutainer lot number 1288653 expiration date 7/31 /22, one tube total. b. All dipotassium ethylenediaminetetraacetic acid (K2EDTA) navy-top tubes: i. BD Vacutainer lot number 1137444 expiration date 5/31/22, two tubes total. c. All dipotassium ethylenediaminetetraacetic acid (K2EDTA) pink-top tubes: i. BD Vacutainer lot number 1014130 expiration date 6/30/22, two tubes total. 2. An interview on 8/8/22 at 9:42 am with the TC confirmed the blood collection tubes listed above had exceeded their expiration dates. ***This is a repeated deficiency from the 7/15/16 recertification survey*** D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and 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 -- identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to include the address of the laboratory where qualitative toxicology testing was performed for 8 (Patients 15244, 17297, 18508, 20105, 21312, 31649, 27148, and 24321) of 12 patient test reports reviewed. Findings include: 1. A review of patient qualitative toxicology test reports revealed 8 of 12 did not indicate the address of the laboratory where testing had been performed: a. Patient 15244 received testing on 6/2/21. b. Patient 17297 received testing on 7/20/21. c. Patient 18508 received testing on 8/30/21. d. Patient 20105 received testing on 10/7/21. e. Patient 21312 received testing on 11/5/21. f. Patient 24321 received testing on 1/25/22. g. Patient 27148 received testing on 3/2/22. h. Patient 31649 received testing on 6/27/22. 2. An interview on 8/8/22 at 10:13 am with the TC confirmed the laboratory did not include the address of the laboratory where qualitative toxicology testing had been performed for the patients listed above on the test report. 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 record review and interview with the Technical Consultant, the laboratory failed to ensure the quality assurance manager, performing the duties of a Technical Consultant, had met the qualification requirements at 493.1411. Findings include: 1. The laboratory failed to ensure personnel performing the Technical Consultant duty of peforming testin personnel competency assessments was qualified. 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 -- 2 of 3 -- 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 record review and interview with the Technical Consultant, the laboratory failed to ensure personnel performing the technical consultant duty of performing testing personnel competency assessments was qualified for 1 (quality assurance manager) of 2 personnel performing testing personnel competency assessments. Findings include: 1. A review of the laboratory's personnel competency records revealed Testing Personnel #1 had a competency assessment performed in June 2022 by the quality assurance manager. 2. The surveyor requested the qualifications of the quality assurance manager on 8/8/22 at 4:54 pm and the documentation was not made available. 3. An email received on 8/12/22 at 10:00 am from the Technical Consultant revealed the quality assurance manager did not have the qualifications to perform the duties of a technical consultant. -- 3 of 3 --

Summary Statement of Deficiencies D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on observation and interviews with the Office Manager and Technical Consultant, the laboratory failed to report SARS-CoV-2 test results as required for 27 tests performed since the laboratory started testing on 5/1/21. Findings include: 1. An observation by the surveyor on 5/24/21 at 9:10 am revealed the laboratory was performing SARS-CoV-2 testing using the Abbott BinaxNOW antigen test cards. 2. An interview with the Office Manager on 5/24/21 at 10:18 am revealed the laboratory is not reporting their SARS-CoV-2 testing results from the Abbott BinaxNOW antigen test cards to the health department. 3. An interview with the Technical Consultant on 5/24/21 at 10:57 am revealed the laboratory had tested 27 patients since the laboratory started testing on 5/1/21. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager, the laboratory failed to have qualitative toxicology test requests from an authorized person for 7 (Patients 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 -- 14026, 1112, 4212, 7794, E2, 33, and 18) of 10 patient test records reviewed. Findings include: 1. A review of the laboratory's testing logs revealed the following patients had qualitative toxicology testing ordered and performed: a. Patient 14026 tested on 04/29/2021 b. Patient 1112 tested on 04/22/2020 c. Patient 4212 tested on 08 /03/2020 d. Patient 7794 tested on 11/10/2020 e. Patient E2 tested on 12/22/2020 f. Patient 33 tested on 06/21/2019 g. Patient 18 tested on 08/31/2019 2. An interview on 5/14/21 at 10:02 am with the Office Manager revealed the laboratory did not have test requests for the patients listed above for those testing dates. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager, the laboratory failed to ensure test results were sent to the final report destination for 3 (Patients 1112, 33, and 18) of 10 patient test records reviewed. Findings include: 1. A review of the laboratory's testing logs revealed the following patients had qualitative toxicology testing ordered and performed: a. Patient 1112 tested on 04/22/2020 b. Patient 33 tested on 06/21/2019 c. Patient 18 tested on 08/31/2019 2. An interview on 5/14/21 at 10:02 am with the Office Manager revealed the laboratory did not have test reports for the patients listed above for those testing dates. 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 record review and interview with the Technical Consultant, the Laboratory Director failed to ensure established quality assessment programs were maintained for 2 (May 2019 to May 2020) of 2 years. Findings include: 1. A review of the laboratory's Quality Assurance policy revealed a section stating, "The director will review all laboratory proficiency testing results and all quarterly and annual QA indicator monitoring done." 2. A review of the laboratory's records revealed a lack of quality assessment reviews from May 2019 to May 2021. 3. An interview on 5/24/21 -- 2 of 3 -- at 10:45 am with the Technical Consultant revealed the laboratory did not perform quarterly and annual quality assessment monitoring in accordance with the established policy. -- 3 of 3 --

Summary Statement of Deficiencies D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on observation and interviews with the Office Manager and Technical Consultant, the laboratory failed to report SARS-CoV-2 test results as required for 27 tests performed since the laboratory started testing on 5/1/21. Findings include: 1. An observation by the surveyor on 5/24/21 at 9:10 am revealed the laboratory was performing SARS-CoV-2 testing using the Abbott BinaxNOW antigen test cards. 2. An interview with the Office Manager on 5/24/21 at 10:18 am revealed the laboratory is not reporting their SARS-CoV-2 testing results from the Abbott BinaxNOW antigen test cards to the health department. 3. An interview with the Technical Consultant on 5/24/21 at 10:57 am revealed the laboratory had tested 27 patients since the laboratory started testing on 5/1/21. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager, the laboratory failed to have qualitative toxicology test requests from an authorized person for 7 (Patients 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 -- 14026, 1112, 4212, 7794, E2, 33, and 18) of 10 patient test records reviewed. Findings include: 1. A review of the laboratory's testing logs revealed the following patients had qualitative toxicology testing ordered and performed: a. Patient 14026 tested on 04/29/2021 b. Patient 1112 tested on 04/22/2020 c. Patient 4212 tested on 08 /03/2020 d. Patient 7794 tested on 11/10/2020 e. Patient E2 tested on 12/22/2020 f. Patient 33 tested on 06/21/2019 g. Patient 18 tested on 08/31/2019 2. An interview on 5/14/21 at 10:02 am with the Office Manager revealed the laboratory did not have test requests for the patients listed above for those testing dates. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager, the laboratory failed to ensure test results were sent to the final report destination for 3 (Patients 1112, 33, and 18) of 10 patient test records reviewed. Findings include: 1. A review of the laboratory's testing logs revealed the following patients had qualitative toxicology testing ordered and performed: a. Patient 1112 tested on 04/22/2020 b. Patient 33 tested on 06/21/2019 c. Patient 18 tested on 08/31/2019 2. An interview on 5/14/21 at 10:02 am with the Office Manager revealed the laboratory did not have test reports for the patients listed above for those testing dates. 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 record review and interview with the Technical Consultant, the Laboratory Director failed to ensure established quality assessment programs were maintained for 2 (May 2019 to May 2020) of 2 years. Findings include: 1. A review of the laboratory's Quality Assurance policy revealed a section stating, "The director will review all laboratory proficiency testing results and all quarterly and annual QA indicator monitoring done." 2. A review of the laboratory's records revealed a lack of quality assessment reviews from May 2019 to May 2021. 3. An interview on 5/24/21 -- 2 of 3 -- at 10:45 am with the Technical Consultant revealed the laboratory did not perform quarterly and annual quality assessment monitoring in accordance with the established policy. -- 3 of 3 --

Summary Statement of Deficiencies 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 review of the 2017, 2018, and 2019 provider performance testing reported to the CLIA database by the American Proficiency Institute (API) and review of the final program reports from API, the laboratory failed to achieve satisfactory performance for the "Cell I.D. or WBC Diff" in 5 of 7 testing events. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of the CMS database and review of the American Proficiency Institute (API) final proficiency testing program reports, the laboratory failed to achieve satisfactory performance in 5 out of 7 consecutive proficiency testing events for the following hematology analyte: Cell Identification (ID) or White Blood Cell (WBC) Differential (Diff). Findings include: 1. Unsatisfactory performance in 5 out of 7 proficiency testing events constitutes subsequent unsuccessful proficiency testing performance. Cell ID or WBC Diff PT Event Score 1st event 2017 7% 2nd event 2017 67%, 3rd event 2017 53% 2nd event 2018 47% 1st event 2019 73% 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 review of the CMS database and review of the American Proficiency Institute (API) proficiency testing program reports, the laboratory director failed to provide overall management and direction in accordance with 493.1407 of this subpart. Findings include: Failure to ensure that the proficiency testing samples were tested as required under subpart H. 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: . Based on review of the CMS database and review of the American Proficiency Institute (API) proficiency testing program reports, the laboratory director failed to ensure the laboratory successfully participated in a proficiency testing program as required under subpart H. Findings include: 1. Unsatisfactory performance in 5 out of the last 7 proficiency testing events for the Cell Identification (ID) or White Blood Cell (WBC) Differential (Diff) testing. Refer to D2016 and D2130. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the CMS database and review of the American Proficiency Institute (API) final graded proficiency testing reports, the laboratory failed to successfully participate in a CMS approved proficiency testing program for the specialty of endocrinology and the analyte thyroid stimulating hormone (TSH). Refer to D2107 and D2108. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) 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 -- 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 proficiency testing (PT) desk review and the laboratory's graded PT results from American Proficiency Institute (API), the laboratory failed to achieve successful performance for the analyte, thyroid stimulating hormone (TSH), in two out of three testing events. Findings include: TSH Score 1st event 2019 60% 2nd event 2018 0% D2108 ENDOCRINOLOGY CFR(s): 493.843(g) Failure to achieve an overall testing event score of satisfactory performance for 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 proficiency testing (PT) desk review and the laboratory's graded PT results from American Proficiency Institute (API), the laboratory failed to achieve an overall successful performance for the specialty of Endocrinology, in two out of three testing events. Findings include: Endocrinology Score 1st event 2019 60% 2nd event 2018 0% -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to retain the temperature charts for 12 (November to December 2016 and January to October 2017) of 24 months reviewed to ensure proper operation of the laboratory testing instruments and the storage of reagents and quality control material. Findings include: 1. On November 13, 2018 at 11:45 AM, record review of the monthly temperature charts for the room temperature, humidity, refrigerator, and freezer readings the laboratory did not retain the following months a follows: a. 2016 - November to December b. 2017 - January to October 2. During the interview on November 13, 2018 at 11:45 AM, technical consultant #2 as listed on the CMS-209 confirmed the daily temperature readings and documentation were not retained. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to have a written request for patient testing from an authorized person for three (#1, #2, and #12) of 13 patient charts audited for the endocrinology thyroid stimulating hormone (TSH) and the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- prostate-specific antigen (PSA) testing and the toxicology urine drug screen (UDS) testing. Findings include: 1. On November 13, 2018 at 1:50 PM, record review for three of 13 patient charts audited revealed the laboratory was not able to show the surveyor the written request for the laboratory testing as follows: a. patient #1 - TSH b. patient #2 - UDS c. patient #12 - PSA 2. During the interview on November 13, 2018 at 1:50 PM, technical consultant #2 as listed on the CMS-209 confirmed the laboratory did not have a written request for the testing performed and documented. 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 record review and interview, the laboratory failed to perform and document the weekly chemistry FREND maintenance as required by the manufacturer for five (January, April, May, July, and August) of 24 months reviewed. Findings include: 1. On November 13, 2018 at approximately 1:00 PM, record review of the "FREND Maintenance Log" revealed the laboratory did not have documentation to show the daily maintenance tasks of: "Power-on Analyzer & view Main Screen, Perform and Print daily System Check, and Wipe Analyzer - dry cloth" were performed on days of operation as follows in 2018: a. January 17 b. April 18 c. May 9 and 21 d. July 6, 18, and 25 e. August 1, 10, and 22 2. During the interview on November 13, 2018 at approximately 1:00 PM, technical consultant #2 as listed on the CMS-209 confirmed the maintenance tasks were not completed and documented as required. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to perform quality control as required for the endocrinology thyroid stimulating hormone (TSH) and prostate-specific antigen (PSA) testing for two (#8 and #11) of 13 patient charts audited. Findings include: 1. On November 13, 2018 at 12:45 PM, record review for the TSH and PSA quality control logs revealed the laboratory did not perform and document at least two levels of controls each day of patient testing for the endocrinology testing as follows: a. TSH b. PSA 2. On November 13 2018 at 12:45 PM when queried, technical consultant #2 as listed on the CMS-209 was not able to provide the surveyor the quality control results for at least two different levels of -- 2 of 4 -- controls for the day of testing for patient #8 and #11. 3. During the interview on November 13, 2018 at 12:45 PM, technical consultant #2 confirmed two levels of controls were not performed and documented and that an individualized quality control plan had not been implemented to decrease the number or frequency of running external controls. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: . Based on document review and interview, the laboratory failed to 1) produce the patients paper charts for two (#1 and #2) of 13 charts audited and 2) maintain the final tests report for four (#4, #10, #11, and #12) of 13 patient charts audited for the endocrinology thyroid stimulating hormone (TSH) and prostate-specific antigen (PSA) and the toxicology urine drug screen (UDS) testing. Findings include: 1. On November 13, 2018 at approximately 12:35 PM, document review revealed the laboratory did not have the final test report maintained as part of the patient's paper chart as follows: a. no chart 1. patient #1 - TSH 2. patient #2 - UDS b. no results in paper chart 1. patient #4 - PSA 2. patient #10 -TSH and PSA 3. patient #11 - PSA 4. patient #12 - TSH and PSA 2. During the interview on November 13, 2018 at approximately 12:35 PM, technical consultant #2 as listed on the CMS-209 confirmed the patient's paper charts and/or the final test reports were not available to the surveyor for review. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: . Based on record review and interview, the laboratory failed to provide the educational requirements for two (#3 and #4) of five testing personnel who perform moderately complex hematology testing. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of -- 3 of 4 -- Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to ensure that all testing personnel met the educational requirements at 493.1423 for two (#3 and #4) of five testing personnel as listed on the CMS-209 performing moderately complex hematology testing. Findings include: 1. On November 13, 2018 at 9:52 AM, record review for two of five testing personnel credentials revealed the educational requirements for performing moderately complex hematology testing was not met. 2. During the interview on November 13, 2018 at 9:52 AM, technical consultant #2 as listed on the CMS-209 confirmed the educational requirements were not met. 3. On November 13, 2018 at 9:52 AM, the laboratory was given five additional days to supply the necessary educational documents. The documents were not received. -- 4 of 4 --

Summary Statement of Deficiencies 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 review of the CMS database and review of the American Proficiency Institute (API) final graded proficiency testing reports, it was determined that the laboratory failed to successfully participate in a CMS approved proficiency testing program for the hematology analyte: cell identification (ID) or white blood cell (WBC) diff. Findings include: Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for two of three proficiency testing events for the hematology analyte: cell ID or WBC diff. Refer to D2130 D2130 HEMATOLOGY 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 -- CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on review of the CMS database and review of the American Proficiency Institute (API) final graded proficiency testing reports, the laboratory failed to achieve satisfactory performance in two out of three consecutive proficiency testing events for the following hematology analyte: Cell Identification (ID) or White Blood Cell (WBC) Differential (Diff).(HCT). Findings include: 1. Unsatisfactory performance in two out of three proficiency testing events constitutes subsequent unsuccessful proficiency testing performance. WBC diff PT Event Score 3rd event 2017 53% 2nd event 2018 47% 2. Unsatisfactory performance in four out of five proficiency testing events constitutes subsequent unsucccessful proficiency testing performance. WBC diff PT Event Score 1st event 2017 7% 2nd event 2017 67% 3rd event 2017 53% 2nd event 2018 47% -- 2 of 2 --