Mary Mahoney Memorial Health Center

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/08/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director and testing person #1 at the conclusion of the survey. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 testing person #1, the laboratory failed to ensure expired supplies were not available for use. Findings include: (1) Observation of the laboratory on 05/08/2025 at 10:20 am, identified the following expired supplies that appeared to be available for use: (a) 25 Microtainer Brand EDTA Tubes, lot #23C4336, expired 03/31/2025; (b) 35 Vacutainer Brand Sodium Citrate Tubes, lot 4198275, expired 04/30/2025. (2) Interview with testing person #1 on 05/08/2025 at 10:20 am confirmed the expired supplies were available for use. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(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. (b)(2)(ii) Perform and document the function checks, including background or 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with testing person #1, the laboratory failed to follow their written protocol for ensuring the urine centrifuge was functioning properly for two of two annual function checks performed during the review period of July 2023 through the current date. Finding include: (1) On 05/08/2025 at 11:00 am, testing person #1 stated the following: (a) Urine sediment examinations were performed by the laboratory; (b) The specimens were processed in the McKesson 602 centrifuge at a speed of 1500 - 2000 rpm (revolutions per minute) for 5 minutes. (2) A review of the procedure titled, "Centrifuge Calibration" stated, "Centrifuges will be calibrated annually for the RPM's and Timer to ensure the speed and times are within acceptable limits and to ensure the quality of testing is not compromised"; (a) "Acceptable RPM's will be between 1500 - 2000 RPM's"; (b)" Acceptable time limit will be 4.9-5.0 minutes". (3) A review of centrifuge function check records from July 2023 through the current date identified the speed check was not within the acceptable limits as follows: (a) On 10/27/2023 the centrifuge speed check was documented at 2202 (RPM); (b) There were no function checks documented in 2024. (4) The records were reviewed with testing person #1, who stated on 05/08/2025 at 11:00 am, the laboratory had not followed their policy for function checks. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/26/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director and laboratory supervisor during an exit conference performed at the conclusion of the survey. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, observation, and interview with the laboratory supervisor, the laboratory failed to follow the manufacturer's instructions for room temperature storage for 16 of 16 reagent cartridges for Hemoglobin A1c testing. Findings include: (1) On 06/26/2023 at 10:32 am, the laboratory supervisor stated Hemoglobin A1c testing was performed using the Siemens DCA Vantage analyzer; (2) Observation of the laboratory on 06/26/2023 at 10:35 am identified 16 DCA Systems Hemoglobin A1c reagent cartridges, lot #0078 stored at room temperature which had not been dated; (3) Review of the manufacturer's package insert under the heading "Cartridge Storage" stated, "Recommended storage is refrigerated at 2-8 C for maximum reagent life. Alternately, the cartridges can remain at room temperature (15-32 C) provided the expiration date on the carton is changed to three months from the date the carton is removed from the refrigerator"; (4) The findings were discussed with the laboratory supervisor who stated on 06/26/2023 at 10:35 am, the cartridges were being stored at room temperature and had not been dated with the three month room temperature expiration date. 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 -- D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to maintain analytic test records to include lot numbers and expiration dates for qualitative serum pregnancy testing for at least 2 years for 17 of 17 months reviewed. Findings include: (1) On 06/26/2023 at 10:40 am, the laboratory supervisor stated qualitative serum pregnancy testing was performed using the Consult Diagnostics hCG Combo Test Cassette; (2) A review of QC (quality control) and patient testing logs for testing performed from January 2022 through May 2023 identified the lot numbers and expiration dates of the test kits and QC materials used during the timeframe had not been documented on the logs; (3) Interview with the laboratory supervisor on 06/26/2023 at 02:00 pm, confirmed the following: (a) The testing logs were photocopied and the lot numbers on the logs were not reflective of the QC and test kits in use; (b) The laboratory did not have a method to maintain records of the lot numbers of QC materials and test kits used for testing during the review period. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to verify the accuracy of Wet Prep testing at least twice annually during the review period of August 2021 through the current date. Findings include: (1) On 06/26/2023 at 10:55 am, the laboratory supervisor stated Wet Prep testing was performed; (2) A review of records from August 2021 through the current date identified the testing had not been verified for accuracy at least twice annually as follows: (a) Prior to 02/22/2022; (b) Between 02/21/2022 and 03/30/2023. (3) The records were reviewed with the laboratory supervisor who stated on 06/26/2023 at 02: 20 pm, the laboratory had not verified the accuracy twice annually as stated 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. -- 2 of 5 -- 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 ensure the humidity was maintained as required by the manufacturer of the Sysmex XS-1000i analyzer for three of five months reviewed in 2023. Findings include: (1) On 06/26/2023 at 10:30 am, the laboratory supervisor stated CBC (Complete Blood Count) testing was performed using the Sysmex XS-1000i analyzer; (2) A review of the manual for the analyzer titled, "Instructions for Use" in Section 11.11 "Installation Environment" stated "Relative humidity should be in the range of 30-85%"; (3) A review of laboratory humidity records from January through May 2023 identified humidity readings were less than 30% for three of five months as follows: (a) January - One of 20 humidity readings were documented as less than 30%; (b) February - One of 20 humidity readings were documented as less than 30%; (c) March - Four of 23 humidity readings were documented as less than 30%. (4) The records were reviewed with the laboratory supervisor who stated on 06/26/2023 at 01:30 pm, the laboratory humidity had not been maintained as required by the manufacturer as shown above. 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 a review of records, observation, and interview with the laboratory supervisor, the laboratory failed to ensure 11 of 11 Microalbumin/Creatinine reagent cartridges had not exceeded their room temperature expiration date. Findings include: (1) On 06/26/2023 at 10:32 am, the laboratory supervisor stated Urine Microalbumin /Creatinine testing were performed using the Siemens DCA Vantage analyzer; (2) Observation of the laboratory on 06/26/2023 at 10:35 am identified 11 DCA Systems Microalbumin/Creatinine reagent cartridges, lot #0065 stored at room temperature which had not been dated; (3) Review of the manufacturer's package insert for the testing under the heading "Use Life" stated, "Reagent cartridges can be kept for up to three months at room temperature anytime before the expiration date. Record on the carton, the date the carton was placed at room temperature"; (4) The findings were discussed with the laboratory supervisor who stated on 06/26/2023 at 10:35 am, the cartridges were being stored at room temperature and had not been dated with the three month room temperature expiration date. 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 ensure the manufacturer's instructions -- 3 of 5 -- were followed for performing maintenance procedures during the review period of August 2021 through May 2023. Findings include: (1) On 06/26/2023 at 10:30 am, the laboratory supervisor stated CBC (Complete Blood Count) testing was performed using the Sysmex XS-1000i analyzer; (2) A review of the manufacturer's maintenance log showed the following required maintenance procedures: (a) Weekly - "Power Down IPU" (b) Monthly - "Perform Monthly Rinse" (3) A review of maintenance logs from August 2021 through May 2023 identified no documentation maintenance had been performed as follows: (a) Weekly - Not documented as performed between: (i) 07 /30/2021 and 10/01/2021 (ii) 12/03/2021 and 01/07/2022 (iii) 02/11/2022 and 02/25 /2022 (iv) 08/19/2022 and 08/28/2022 (v) 03/17/2023 and 04/03/2023 (b) Monthly - Not documented as performed between: (i) 07/08/2021 and 10/14/2021 (ii) 04/25 /2022 and 06/28/2022 (4) The records were reviewed with the laboratory supervisor who stated on 06/26/2023 at 01:50 pm, the maintenance had not been documented as performed as shown above. 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 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 for two of two function checks performed during the review period of August 2021 through the current date. Finding include: (1) On 06/26/2023 at 10:45 am, the laboratory supervisor stated the following: (a) Urine sediment examinations were performed; (b) The specimens were processed in the McKesson Unico centrifuge at a speed of 1500-2000 rpm (revolutions per minute) for 5 minutes; (2) A review of the centrifuge function check records confirmed the centrifuge speed and timer were checked annually; (3) A review of the procedure titled, "Steps in Preparing a Concentrated Urine Sediment" stated "Centrifuge at the speed and spin time specified in your laboratory's procedure. 1500-2000 rpms for 5 minutes"; (4) A review of centrifuge function check records during 2021 through the current date identified the centrifuge speed and timer had not been checked at the speed and time urines were processed for two of two checks performed as follows: (a) 10/30/2021 - The speed had been checked at 2200 rpm and the timer had been checked at ten minutes; (b) 10/28/2022 - The speed had been checked at 2200 rpm and the timer had been checked at ten minutes. (5) The records were reviewed with the laboratory supervisor who stated on 06/26/2023 at 03:30 pm, the laboratory had not followed their policy. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) -- 4 of 5 -- (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, observation, and interview with the laboratory supervisor, the laboratory failed to follow the manufacturer's specifications for ensuring the correct control limits for the analyte platelets were programmed in the Sysmex XS-1000i analyzer for one of three levels of controls. Findings include: (1) On 06/26/2023 at 10:20 am, the laboratory supervisor stated: (a) CBC (Complete Blood Count) testing was performed using the Sysmex XS-1000i analyzer; (b) Three levels of Sysmex e-Check QC (quality control) materials were performed each day of patient testing; (c) When new lot numbers of QC materials were put into use the laboratory established their own means, and the limits of acceptability were calculated based on the manufacturer's Evidence Based Control Limits, that were programmed in the analyzers memory. (2) Observation of the Evidence Based Control Limits programmed into the analyzer on 06/26/2023 at 10:25 am, identified the limit for the analyte Platelets level one had been entered as 80%; (3) Review of the Sysmex "Product Information" sheet which provided the Evidence Based Control limits to be used for each analyte stated the limits for Platelets level one was 23%; (4) The findings were discussed with the laboratory supervisor who stated on 06/26/2023 at 10:30 am, the manufacturer's stated Evidence Based limit for Platelets level one had not been entered into the analyzer accurately. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/01/2021. The findings were reviewed with the laboratory director and laboratory supervisor 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 and interview with the laboratory supervisor, the laboratory failed to have a written clinical consultant competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) The surveyor reviewed personnel records for competency assessments performed during 2019, 2020, and to date in 2021. There was no evidence competencies had been performed for clinical consultant based on job responsibilities; (2) The surveyor asked the laboratory supervisor if a written policy to evaluate the clinical consultant, based on job responsibilities, was available and if competencies had been performed during the review period. The laboratory supervisor stated to the surveyor on 07/01/2021 at 03: 38 pm, a policy to evaluate the clinical consultant based on job responsibilities had not been written; and competencies had not been performed. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. 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 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to verify the accuracy of Wet Prep analysis at least twice annually. Findings include: (1) On 07/01/2021 at 09:40 am, the laboratory supervisor stated to the surveyor the laboratory performed Wet Prep analysis; (2) The surveyor reviewed 2019 and 2020 records, which showed the testing had not been verified for accuracy twice in 2019 and 2020. Wet Prep analysis had not been verified for accuracy prior to 05/19/2020; (3) The surveyor reviewed the records with the laboratory supervisor who stated on 07/01/2021 at 03:48 pm, Wet Prep analysis had not been verified for accuracy at least twice annually in 2019 and 2020. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of the policy and procedure manual and interview with the laboratory supervisor, the laboratory failed to follow written procedures for CBC (Complete Blood Test) testing performed for 6 of 9 quality control lot numbers. Findings include: (1) On 07/01/2021 at 09:35 am, the laboratory supervisor stated to the surveyor CBC (Complete Blood Count) testing was performed on the Sysmex XS- 1000i analyzer; (2) The surveyor reviewed written laboratory procedure titled, "Lab Policies Volume:2" under the section titled, "V. QUALITY CONTROL" stated, (a) "F. Auto-Set Targets" (i) "Parallel test new controls by analyzing each level of control a minimum of twice a day for 5 days prior to expiration of the previous lot. After a minimum of 10 data points are accumulated, auto-set the targets," (3) The surveyor reviewed 9 QC (quality control) lot numbers. For 6 of 9 lot numbers there was no indication the laboratory staff followed their written procedure as follows: (a) Lot# 03500804 ran 1 time before put into use on 01/10/2021; (b) Lot# 03500805 ran 1 time before put into use on 01/10/2021; (c) Lot# 03500806 ran 1 time before put into use on 01/10/2021; (d) Lot# 10860804 ran 1 time before put into use on 04/19/2021; (e) Lot# 10860805 ran 1 time before put into use on 04/19/2021; (f) Lot# 10860806 ran 1 time before put into use on 04/19/2021. (4) The surveyor reviewed the findings with the laboratory supervisor. The laboratory supervisor stated on 07/01/2021 at 04:20 pm that the procedure had not been followed as indicated above. 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 a review of the procedure manual and interview with the laboratory supervisor, the laboratory failed to ensure written policies and procedures had been -- 2 of 8 -- approved, signed, and dated by the laboratory director. Findings include: (1) On 07/01 /2021 at 09:35 am, the laboratory supervisor stated to the surveyor the laboratory performed the following moderately complex testing: (a) Routine CBC(Complete Blood Count) testing was performed using the Sysmex XS-1000i analyzer; (b) Microalbumin testing was performed using the Siemens DCA Vantage analyzer; (c) Urine Sediment examinations; (d) Wet Prep examinations. (2) The surveyor reviewed the following laboratory manuals titled,"Lab Policies Volume:1" and "Lab Policies Volume:2", which contained written policies and procedures. There was no indication the manual had been approved, signed, and dated by the laboratory director; (3) The surveyor showed the manual to the laboratory supervisor. The laboratory supervisor stated on 07/01/2021 at 04:10 pm, the documentation to prove the contained policies and procedures had been signed and dated by the laboratory director could not be located. 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 laboratory supervisor, the laboratory failed to follow the manufacturer's instructions for verifying morphology flags for 3 of 6 patient reports. Findings include: (1) On 07 /01/2021 at 09:35 am, the laboratory supervisor stated that CBC (Complete Blood Count) testing was performed on the Sysmex XS-1000i analyzer; (2) The surveyor reviewed the manufacturer's instructions for verifying morphology flags obtained on the analyzer. The following were examples of flags, with the corresponding instructions: (a) Anemia - "Verify RBC morphology on slide" (b) Dimorphic Population - "Verify RBC morphology on slide" (c) HGB Defect - "Verify RBC morphology on slide" (d) Lymphocytosis - "Review manual smear" (e) Microcytosis - "Verify RBC morphology on slide" (f) Monocytosis - "Review manual smear" (g) Neutrophilia - "Review manual smear" (h) PLT Abn Distribution - "Verify presence on slide" (i) PLT Clump(s) - "Verify on slide" (j) RBC Abn Distribution - "Verify presence on slide" (3) The surveyor randomly reviewed 6 patient records which contained morphology flags from CBC testing performed on 09/01/2020, 09/04/2020, 09/21/2020, 09/22/2020, and 01/08/2021. For 3 of the records, there was no evidence the laboratory followed the manufacturer's instructions for verifying the flags. The findings for the 3 records were: (a) Testing was performed on 09/01/2020 at 02:12 pm, with RBC Abn Distribution, Dimorphic Population, and Anemia flags obtained; (b) Testing was performed on 09/01/2020 at 11:18 am, with a Microcytosis flag obtained; (c) Testing was performed on 09/22/2020 at 02:07 pm, with an Monocytosis flag obtained. (4) The surveyor reviewed the records with the laboratory supervisor, who stated on 07/01/2020 at 04:41 pm that the flags obtained for the above 3 patients had not been verified D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other -- 3 of 8 -- 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 a review of manufacturer's instructions and interview with the laboratory supervisor, the laboratory failed ensure quality control materials were not used beyond open vial stability for 1 of 1 lot numbers. Findings include: (1) On 07/01/2020 at 09: 45 am, the laboratory supervisor stated to the surveyor the laboratory performed CBC (Complete Blood Count) testing using the Sysmex XS-1000i analyzer; (2) The surveyor observed at 10:00 am the following control material stored in the laboratory refrigerator:: (a) Sysmex e-CHECK Tri-Level control materials: (i) 1 bottle of low control lot# 11520804 (ii) 1 bottle of normal control lot# 1152805 (iii) 1 bottle of high control lot# 11520806 (3) The surveyor asked the laboratory supervisor to explain what the controls were used for. The laboratory supervisor explained the following: (a) Sysmex e-CHECK Tri-Level controls were used to perform quality control procedures for CBC testing performed on the Sysmex XS-1000i analyzer. (4) The surveyor reviewed the manufacturer's open date stability instructions, which stated the following: (a) "Opened and recapped vials and vials whose caps have been pierced will retain stability for 14 days if stored at 2-8C."; (b) The quality control materials had been dated as opened on 06/14/2021 and were available for use on the day of the survey (17 days). (5) The surveyor reviewed the instructions and the open dates on the control bottles with the laboratory supervisor, who stated on 07/01/2021 at 10:00 am the controls were available for use beyond the manufacturer's open vial expiration date. 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 perform maintenance procedures as required by the manufacturer for 1 of 11 months. Findings include: SYSMEX XS- 1000i ANALYZER (1) On 07/01/2021 at 09:50 am, the laboratory supervisor stated to the surveyor CBC (Complete Blood Count) testing was performed on the Sysmex XS-1000i analyzer; (2) The surveyor reviewed the manufacturer's weekly maintenance requirement for the analyzer, as stated on the manufacturer's maintenance log titled "XS-1000i MAINTENANCE LOG", which was: (a) "Power Down IPU" (3) Maintenance records were reviewed by the surveyor for 11 months (January 2020 through November 2020). The weekly maintenance had not been documented as performed between: (a) 04/24/2020 and 06/05/2020 (4) The surveyor reviewed the records with the laboratory supervisor. The laboratory supervisor stated on 07/01/2020 at 04:00 pm, there was no evidence the above maintenance had been performed as required. SIEMENS DCA VANTAGE ANALYZER (1) On 07/01/2021 at 09:55 am, the laboratory supervisor stated to the surveyor Microalbumin testing was performed on the Siemens DCA Vantage analyzer; (2) The surveyor reviewed the manufacturer's weekly maintenance requirement for the analyzer, as stated on the manufacturer's maintenance log which was: (a) "CLEAN EXTERIOR"; (b) "CLEAN -- 4 of 8 -- BAR CODE WINDOW" (3) Maintenance records were reviewed by the surveyor for 11 months (January 2020 through November 2020). The weekly maintenance had not been documented as performed between: (a) 04/27/2020 and 06/01/2020 (4) The surveyor reviewed the records with the laboratory supervisor. The laboratory supervisor stated on 07/01/2020 at 04:04 pm, there was no evidence the above maintenance had been performed as required. 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 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 manager, the laboratory failed to follow the function check protocol to ensure the urine centrifuge was functioning properly for 2 of 2 function checks performed. Findings include: (1) On 07/01/20201 at 09:35 am, the laboratory manager stated the following to the surveyor: (a) The laboratory performed microscopic urine sediment examinations; (b) The laboratory used the Unico centrifuge to process urine at a speed between 1500 - 2000 rpm (revolutions per minute) for 5 minutes; (2) The surveyor reviewed the function check policy titled, "Centrifuge Calibration" which stated, "Centrifuges will be calibrated annually for the RPM's and Timer to ensure the speed and times are within acceptable limit and to ensure the quality of testing is not compromised." (a) "Acceptable RPM's will be between 1500 - 2000 RPM's for Urinalysis." (b) "Acceptable time limit will be 4.9 - 5.0 minutes for Urinalysis." (3) The surveyor reviewed the centrifuge maintenance records for 2019 and 2020. The following was identified for 2 of 2 checks performed: (a) 10/20/2019 - The speed had been checked at 2420 rpm an the timer had been checked at 10 minutes, which were not the speed and time settings that urine specimens were processed; (b) 10/21/2020 - The speed had been checked at 3348 rpm an the timer had been checked at 10 minutes, which were not the speed and time settings that urine specimens were processed. (4) The surveyor reviewed the findings with the laboratory manager who stated on 07/01/2021 at 01:15 pm, the laboratory did not ensure the urine centrifuge was functioning properly as indicated above. 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 -- 5 of 8 -- 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 failed to have control procedures that monitored the accuracy and precision of the testing process for 3 of 3 quality control lot numbers. Findings include: (1) On 07/01/2021 at 09:35 am, the laboratory supervisor stated the following: (a) CBC (Complete Blood Count) testing was performed using the Sysmex XS-1000i analyzer; (b) Three levels (low, normal, and high) of Sysmex e-check XS quality control materials were tested each day that patient testing was performed. (2) The surveyor reviewed quality control records. The records indicated that low control (lot #10400804), normal control (lot #10400805), and high control (lot #10400806) had been put into use on 03/05/2021 and used through 04/19/2021; (3) The surveyor requested QC (quality control) records (i.e., Levey-Jennings data) for the above testing performed from 03/05/2021 through 04/19/2021 to ensure QC had been monitored for variances (i.e. shifts, trends, biases). The lead tech stated on 07/01/2021 at 04:35 pm, there were no records (i.e., Levey-Jennings data) proving the control results had been monitored for variances during the review period because data had not been printed and maintained. The surveyor was able to verify that QC had been performed each day of patient testing, however, there was no documentation the data had been reviewed for variances by the laboratory. 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 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 a review of records and interview with the laboratory supervisor, the laboratory failed to ensure patient test reports included the address of the laboratory location where the testing was performed. Findings include: (1) On 07/01/2021 at 09: 45 am, the laboratory supervisor stated the following to the surveyor: (a) CBC (Complete Blood Count) testing was performed using the Sysmex XS-1000i analyzer. (2) The surveyor reviewed a patient CBC report (CBC testing performed on 07/01 /2021). The report did not include the address of the laboratory location; (3) The surveyor reviewed the report with the laboratory supervisor. The laboratory supervisor stated on 07/01/2021 at 03:45 pm, the reports did not include the address of the laboratory location. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 -- 6 of 8 -- 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 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 for 1 of 4 competency evaluations. Findings include: (1) On 07/01/20201, the surveyor -- 7 of 8 -- reviewed records for 4 persons performing moderate complexity testing in 2019, 2020, and 2021. The records showed the evaluations for 1 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- The 04/29/2019 and 08/04/2020 evaluations had been performed by the laboratory supervisor (this person had earned an associate degree in an applied science). (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). The laboratory supervisor stated to the surveyor on 07 /01/2021 at 12:15 pm, the evaluations had been performed by an individual who did not meet the years of experience of a technical consultant. -- 8 of 8 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/04/19. The laboratory was found out of compliance with the following CLIA regulation: 493.1409; D6033: Technical Consultant The findings were reviewed with the laboratory director/technical consultant and laboratory manager during an exit conference performed 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 laboratory supervisor, the laboratory failed to maintain a copy of all records, and the laboratory director and/or testing person failed to sign proficiency testing attestation statements. Findings include: (1) During the survey, the surveyor reviewed 2018 and 2019 proficiency testing records and identified the following for 5 of 11 events: (a) First 2018 Chemistry Miscellaneous Event - The attestation statement had not been signed by the laboratory director; (b) Second 2018 Chemistry Miscellaneous Event - The attestation statement had not been signed by the laboratory director and testing person(s); (c) Second 2018 Chemistry Core Event - The attestation statement and copy of 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 7 -- submitted results had not been maintained; (d) Second 2018 Hematology Event - The attestation statement had not been signed by the laboratory director; (e) First 2019 Chemistry Core Event - The attestation statement had not been signed by the laboratory director. (2) The surveyor reviewed the findings with the laboratory supervisor who stated the attestations had not been signed and the records had not been maintained as indicated above. 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 and interview with the laboratory supervisor, the laboratory failed to have a written clinical consultant and technical consultant competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) During the survey, the surveyor reviewed personnel records for competency assessments performed during 2017, 2018, and to date in 2019. There was no evidence competencies had been performed for the clinical consultant and technical consultant, based on their job responsibilities; (2) The surveyor asked the laboratory manager if a written policy to evaluate the clinical consultant and technical consultant based on job responsibilities was available and if competencies had been performed during the review period. The laboratory supervisor stated a policy to evaluate the clinical consultant and technical consultant based on job responsibilities had not been written; and competencies had not been performed. 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 laboratory supervisor, the laboratory failed to review and evaluate proficiency testing results. Findings include: (1) During the survey, the surveyor reviewed 2018 and 2019 Hematology proficiency testing records. The following failure was identified, for which