Ummc - Grenada

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (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 observation of the Reference Time entered in the primary STA Compact MAX coagulation analyzer, Serial #CF79045261, and the back-up STA Compact MAX coagulation analyzer, Serial #0000008590, review of the establishment of the geometric mean of the normal patient reference range for the current lot of STA- Neoplastine C1 Plus prothrombin time (PT) reagent, Lot #265568, for the primary and back-up analyzers, manufacturer's instructions for the STA Compact MAX coagulation analyzer, and patient test counts, the laboratory failed to follow manufacturer's instructions for setting up the two STA Compact MAX coagulation systems to calculate the INR (international normalized ratio) for patient prothrombin time testing when PT reagent Lot #265568 was put in use for patient testing for seven of seven months. Findings include: 1. Manufacturer's instructions for the Stago STA Compact coagulation analyzer state to enter the geometric mean of the normal patient reference range as the Reference Time with each new lot of PT reagent for correct calculation of the INR. 2. Review of documentation of the establishment of the geometric mean of the normal patient reference range for STA-Neoplastine C1 Plus PT reagent Lot #265568, put in use on 8/1/2024, revealed the geometric mean was calculated as 13.9 for the primary STA Compact MAX analyzer, and the geometric mean was calculated as 13.6 for the back-up analyzer. 3. The Reference Time observed on 3/13/2025 at 11:00 a.m. in the primary and back-up STA Compact MAX analyzers was 13.5. 4. Review of patient test counts revealed 1,658 patient PT results were reported from 8/1/2024 until 3/13/2025. 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 -- D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on review of quality control (QC) logs, patient testing logs, interview with the Laboratory Manager and testing personnel (TP) #3 as listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, and lack of Individualized Quality Control Plan (IQCP), the laboratory failed to include a positive and negative control on each day of patient testing for the two Profile V-MedTox Scan Drug Screen Test readers. Findings Include: 1. Review of the MedTox Drug Screen patient test logs and QC log from 7/2/2023 through 1/27/2025 revealed that QC material was performed weekly on the MedTox Drug Screen reader instead of daily as required. The drug panel the laboratory tested consisted of twelve drugs performed on the MedTox Scan Drug Screen readers: reader #1 -serial number 2919M1847 and reader #2 serial number 1322M1909. 2. Interview with Laboratory Manager and TP #3 on 3/12/2025 at 1:00 p.m., confirmed that testing personnel were not performing two levels of QC (positive or negative) each day of patient testing with the Profile V-MedTox Scan Drug Screen Test readers. 3. There was no IQCP available for review on the day of the survey. An IQCP is required if two levels of quality control (QC) are not performed each day of use for moderate/high complexity testing. Approximately 3500 drug screen panels were performed on both Profile V- MedTox Scan Drug Screen systems since the last survey on 6/22/2023. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood shall be stored in a clean and orderly environment in a manner to prevent mix-ups. Expired blood must not be in the routine inventory. Unacceptable units must be segregated from routine inventory. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. This STANDARD is not met as evidenced by: A. Based on review of blood bank maintenance logs from 7/1/2023 through 1/31/2025 and continuous-monitoring temperature charts for Blood Bank Refrigerator #3, used for storage of packed red blood cells, and the Plasma Freezer from 7/3/2023 through 1 /28/2025, the laboratory failed to document, as performed, quarterly blood bank refrigerator and plasma freezer temperature alarm checks, according to the laboratory's policy, for six of seven quarters from July 2023 through January 2025. Findings include: 1. Review of the blood bank maintenance logs from 7/1/2023 through 1/31/2025 revealed the laboratory's policy included a quarterly temperature alarm check for Blood Bank Refrigerator #3 and the plasma freezer, to be performed in the months of January, April, July, and October. 2. There was no documentation of a quarterly temperature alarm check for Blood Bank Refrigerator #3 or the plasma freezer for July and October 2023; April, July, and October 2024; and January 2025, according to laboratory policy. 3. Review of continuous-monitoring temperature charts for Blood Bank Refrigerator #3 and the plasma freezer revealed no temperature fluctuations on the temperature charts for these months, to indicate that alarm checks were performed. B. Based on review of Blood Bank Refrigerator #3 continuous- -- 2 of 5 -- monitoring temperature charts from 7/3/2023 through 1/28/2025, Blood Bank Refrigerator #3 temperature logs, and blood bank transfusion records, the laboratory failed to ensure blood was stored under appropriate conditions for the weeks of 12/24 /2024 through 12/30/2024 and 1/13/2025 through 1/20/2025, when units of packed red blood cells (PRBC) were stored for transfusion. Findings include: 1. Review of Blood Bank Refrigerator #3 continuous-monitoring temperature charts from 7/3/2023 through 1/28/2025 revealed no temperature recorder graphs for the weeks of 12/24 /2024 through 12/30/2024 and 1/13/2025 through 1/20/2025. 2. Review of Blood Bank Refrigerator #3 temperature logs from 7/1/2023 through 1/31/2025 revealed the temperature of Blood Bank Refrigerator #3 was manually recorded on the logs only once per day, which did not ensure continuous storage under appropriate conditions. 3. Review of blood bank transfusion records for the weeks of 12/24/2024 through 12 /30/2024 and 1/13/2025 through 1/20/2025 revealed units of PRBC were stored for transfusion during this time frame. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: A. Based on review of Gem Premier 5000 Blood Gas analyzers (SN #22041624) and (SN #22041621) quality control and calibration records, confirmation by Respiratory Supervisor and Technical Consultant #2, listed on the CMS 209 personnel form and lack of documentation of comparison of results for blood gases (pH, pO2, pCO2) testing between both Gem Premier 5000 analyzers, the laboratory failed to evaluate the relationship between the results of blood gases performed using different methods, at least twice a year. Findings include: 1. Review of the Gem Premier 5000 Blood Gas analyzers (SN #22041624) and (SN#22041621) records from 7/10/2023 through 3/13 /2025, revealed no documentation of comparison of results for pH, pCO2 and pO2 testing between the two analyzers. 2. The Respiratory Supervisor and Technical Consultant #2 both confirmed that a comparison between both Gem Premier 5000 Blood Gas analyzers was not performed twice annually. Four of four evaluations were not performed since 6/22/2023. B. Based on review of the Profile V-Med Tox Scan DOA (drugs of abuse) system (SN #2919M1847) and (SN #1322M1909) quality control and records, confirmation by Technical Consultant #2 listed on the CMS 209 form and laboratory manager, and lack of documentation of comparison of results for drugs of abuse testing between both Med Tox DOA systems, the laboratory failed to evaluate the relationship between the results of DOA testing performed using different methods, at least twice a year. Findings include: 1. Review of the Med Tox DOA systems (SN #2919M1847) and (SN #1322M1909) records from 7/2/2023 through 1 /27/2025, revealed no documentation of comparison of results for amphetamine, barbiturates, benzodiazepine, cannabinoids, cocaine, methamphetamine, methadone, opiates, oxycodone, phencyclidine, propoxyphene and tricyclic antidepressants testing between the two analyzers since 8/3/2023. 2. The Technical Consultant #2 and laboratory manager both confirmed that a comparison between both MedTox DOA systems was not performed twice annually. Three of four evaluations were not performed since 6/22/2023. C. Based on review of verification of performance specifications for the Stago STA Compact MAX back-up coagulation analyzer (Serial -- 3 of 5 -- #0000008590) performed at installation, interview with the laboratory manager, and lack of documentation of comparison of results for prothrombin time (PT), activated partial thromboplastin time (APTT), D-dimer, and fibrinogen testing between the Stago STA Compact MAX back-up coagulation analyzer and the Stago STA Compact MAX primary coagulation analyzer (Serial #CF79045261), the laboratory failed to evaluate the relationship between the results of PT, APTT, D-dimer, and fibrinogen testing using different methods, at least twice a year. Findings include: 1. Review of verification of performance specifications for the Stago STA Compact MAX back-up coagulation analyzer revealed a comparison of PT, APTT, D-dimer, and fibrinogen testing with the Stago STA Compact MAX primary coagulation analyzer was performed on 11/15/2023. 2. Review of records for the primary and back-up Stago STA Compact MAX coagulation analyzers from 11/15/2023 through 3/13/2025 revealed no documentation of comparison of results for PT, APTT, D-dimer, and fibrinogen testing between the two analyzers. Two of the two evaluations due in 2024 were not performed. 3. In an interview on 3/13/2025 at 3:20 p.m., the Laboratory Manager confirmed that there was no documentation of a comparison between the two Stago STA Compact MAX coagulation analyzers since 11/15/2023. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: A. Based on review of respiratory testing personnel (TP) as listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interview with the General Supervisor (GS) and Respiratory Supervisor, the Technical Consultant (TC) failed to evaluate and document the performance of four of fourteen blood gas testing personnel at least semiannually during the first year of moderate complexity (blood gas) testing. Findings include: 1. Review of the respiratory (blood gas) personnel records since the last survey on 6/22/2023 revealed no semiannual competency evaluations were available for the performance of four of fourteen respiratory testing personnel. a. TP #15 initial training-07/19/2024, semiannual evaluation due-01/2025 b. TP #18 initial training-05/26/2023, semiannual evaluation due-08/2023 c. TP #19 initial training-06/26/2023, semiannual evaluation due-12/2023 d. TP #20 initial training-09/18/2023, semiannual evaluation due-03/2024 2. The General Supervisor and Respiratory Supervisor confirmed in an interview on 3/12/2025 at 3:00 p.m., there was no semiannual competency evaluations performed on TP #15, TP #18, TP #19 and TP #20 by the TC. B. Based on review of laboratory personnel records including the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interviews with the General Supervisor (GS) and Laboratory Manager, the Technical Consultant (TC) failed to evaluate and document the performance of two of nine testing personnel responsible for performing moderate complexity laboratory testing at least semiannually during the first year of employment. Findings Include: 1. Review of the laboratory personnel records since the last survey on 6/22/2023, revealed no semiannual competency evaluations were available for the performance of two of nine laboratory testing personnel. a. TP #11-initial training-5/17/2023; semiannual evaluation due-11/2023 b. TP #13-hire date 6/18/2024; semiannual -- 4 of 5 -- evaluation due 12/2024 2. The General Supervisor and Laboratory Manager confirmed in an interview on 3/11/2025 at 2:30 p.m., there was no semiannual competency evaluations performed on TP #11 and TP #13 by the TC. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records including the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interviews with the General Supervisor (GS) and the Laboratory Manager, the Technical Supervisor (TS) failed to evaluate and document the performance of two of nine testing personnel responsible for performing high complexity laboratory testing at least semiannually during the first year of employment. Findings Include: 1. Review of the laboratory personnel records since the last survey on 6/22/2023, revealed no semiannual competency evaluations were available for the performance of two of nine laboratory testing personnel. a. TP #11-initial training-5/17/2023; semiannual evaluation due-11/2023 b. TP #13-hire date 6/18/2024; semiannual evaluation due 12/2024 2. The General Supervisor and Laboratory Manager confirmed in an interview on 3/11/2025 at 2:30 p. m., there was no semiannual competency evaluations performed on TP #11 and TP #13 by the TS. -- 5 of 5 --

Summary Statement of Deficiencies 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 review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, laboratory personnel records since 12/2/2021 and confirmation with the technical consultant (TC) #2, the laboratory failed to follow written policies to assess general supervisor (GS) and TC competency. The competencies available the day of survey were performed by someone other than the laboratory director. Findings include: 1. Based on review of the personnel records and the CMS-209 personnel form, the laboratory failed to follow written policies and procedures to evaluate the competencies of the following technical consultants (TC) and general supervisors (GS) at least annually since the last survey: a. TC #2/GS #1- No general supervisor or technical consultant competency for 2022 and 2023 b. TC #3/GS #2- No general supervisor or technical consultant competency for 2022 and 2023 by LD c. TC #4/GS #3- No general supervisor or technical consultant competency for 2022 and 2023 2. TC#2/GS#1 confirmed in an interview at 1:00 p.m. on 6/22/2023 that the laboratory failed to follow policies to assess general supervisor and technical consultant competency. 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 4 -- This STANDARD is not met as evidenced by: Based on review of laboratory proficiency testing records, lack of documentation of twice annual verifications on the Procalcitonin assay, and interview with technical consultant (TC) #2 listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form on 6/22/2023 at 12:15 P.M., the laboratory failed to verify the accuracy of Procalcitonin testing twice per year for 4 of 4 verifications due since testing began on 8/25/2021. Findings included: 1. Review of proficiency testing records and lack of verification records for Procalcitonin revealed no twice annual test verification was performed for 4 of 4 verifications due between 8/25/2021 and 6/22 /2023. The laboratory performs approximately 1,445 Procalcitonin tests each year. 2. During an interview on 6/22/2023 at 12:15 P.M., technical consultant # 2 confirmed no twice annual test verifications for Procalcitonin were performed. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: A. Based on review of the Gem Premier 5000 blood gas analyzer records including quality control, maintenance, and calibration verification records from installation on 8 /24/2022 through 6/22/2023 and confirmation with the respiratory testing personnel (TP) #1 and technical consultant (TC) #2 as listed on the Centers for Medicare and Medicaid Services 209 personnel form at 12:00 p.m. on 6/22/2023, the laboratory failed to document as performed calibration verification on the Gem Premier 5000 blood gas analyzer every 6 months for pCO2, pH, pO2. One of three calibration verifications was missed during the timeframe reviewed, and one of three calibration verifications exceeded the sixth month timeframe required by the manufacturer. Findings include: 1. Calibration verification is required every 6 months on any assay which is calibrated with less than 3 levels of calibration material. The Gem Premier 5000 blood gas analyzer uses a single calibrator level to perform calibrations. 2. The Gem Premier 5000 blood gas analyzer records revealed calibration verification was performed during installation on 8/24/2022 and again on 6/6/2023. 3. The respiratory -- 2 of 4 -- TP #1 and TC #2 confirmed in an interview at 12:00 p.m. on 6/22/2023 that calibration verification on pH, pCO2 and pO2 was not performed at the appropriate timeframe or frequency during the period of time reviewed. One of three verifications required was not performed and exceeded the 6 month timeframe required by the manufacturer. B. Based on review of laboratory chemistry records from 12/2/2021 through 6/22/2023 and interview with the laboratory testing personnel (TP) #2 at 3:00 p.m. on 6/21/2023, the laboratory failed to document as performed calibration verification on the two Cobas 6000--501c and e601--chemistry analyzers every 6 months for 51 chemistry analytes. Two of four verifications due were not performed. One of four verifications exceeded the recommended time frame. Findings include: 1. Review of the Cobas 6000 501c and Cobas e601 calibration verification records revealed that 51 chemistry tests are calibrated with a 2 point calibrator. Assays which are calibrated with two point calibrators include: Hemoglobin A1c, Acetaminophen, Albumin, Alkaline Phosphatase, ALT, Amylase, AST, Vitamin B12, BUN, Calcium, Cholesterol, CK, CO2, Creatinine, Direct Bilirubin, ETOH, Ferritin, Folate, free T3, free T4, GGT, Glucose, Hepatitis B Surface Antigen, beta-hCG, HDL Cholesterol, Iron, Lactic Acid, LDH, Lipase, Microalbumin, Magnesium, Ammonia, Prealbumin, Procalcitonin, Phosphorus, Pro-BNP, Rubella IgG, Salicylate, Thyroxine, T4, Total Bilirubin, Troponin, Total Protein, PSA, Triglyceride, TSH, Uric Acid, Vitamin D, Sodium, Potassium, Chloride. 2. Calibration verification is required on any assay which is calibrated with less than 3 calibration materials. 3. Calibration verification was performed and completed on the listed chemistry analytes on 1/5/22 and 4/21 /2023. 4. The technical consultant /TP #2 confirmed in an interview at 3:00 p.m. on 6 /21/2023 that chemistry calibration verifications were not performed every 6 months during the period of time reviewed from 12/2/2021 to 4/21/2023. Two of four verifications required were not performed and and one of the four performed exceeded the 6 month required timeframe. D5503 BACTERIOLOGY CFR(s): 493.1261(a)(2) (a) The laboratory must check the following for positive and negative reactivity using control organisms: (a)(2) Each week of use for gram stains. This STANDARD is not met as evidenced by: Based on review of microbiology patient and quality control (QC) records, microbiology procedure manual, and interview with general supervisor (GS) # 4 listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form on 6 /20/2023 at 2:00 P.M. the laboratory failed to perform QC each day of gram stain testing on 8 of 8 days from 12/2/2021 through 6/20/2023. Findings include: 1. Review of the microbiology patient and QC records indicated the laboratory did not perform a gram negative and gram positive control each day of patient testing from 12/2/2021 through 6/20/2023 for 8 out of 8 patient gram stains reported. 2. During an interview at 2:00 P.M. on 6/20/2023, GS #4 confirmed the laboratory did not perform QC daily with each patient gram stain as required in the microbiology procedure manual. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on review of respiratory department testing personnel records since the last survey 12/2/2021, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interview with technical consultant (TC) #2 at 1:00 p.m. on 6/22 /2023, a TC failed to evaluate and document the performance of three of nine respiratory testing personnel TP #4, TP #5 and TP #10 at least semiannually during the first year of moderate complexity (blood gas) testing. Findings include: 1. Review of the laboratory personnel records indicated that there were no 6-month evaluations available for respiratory TP #4, TP#5 and TP#10. TP #4 initial training date 7/19/2022 - 6 month evaluation due January 2023 TP #5 initial training date 7/19/2022 - 6 month evaluation due January 2023 TP #10 initial training date 7/19/2022 - 6 month evaluation due January 2023 2. TC#2 confirmed in an interview at 1:00 p.m. on 6/22 /2023 that no 6 month evaluation/competency was performed on respiratory TP #4, #5 or #10 during the first year performing moderate complexity (blood gas) testing. Three of nine new respiratory department testing personnel did not have a 6 month evaluation /competency at the appropriate time. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of respiratory testing personnel (TP) records including the Centers of Medicare and Medicaid Services (CMS) 209 personnel form and interview with the technical consultant (TC) #2, a TC failed to evaluate annually and document the performance of five of twelve respiratory testing personnel (TP) #1, TP #3, TP #8, TP #9, and TP #11 responsible for performing blood gas testing. Findings include: 1. Based on respiratory personnel records available for review on the day of survey, the evaluation/competencies were not documented as performed or performed by other than a qualified TC on the following respiratory TP since 12/2/2021: TP #1 - No annual evaluation for 2022 TP #3 - 2021 and 2023 evaluations performed by someone other than a qualified TC TP #8 - No annual evaluation for 2022 TP #9 - No annual evaluation for 2022 and 2023 TP #11 - No annual evaluation for 2021 2. Interview with TC #2 confirmed no annual evaluation/competencies for respiratory TP #1, TP #8, TP #9, and TP #11 had been documented as performed by a TC for the year 2021 and TP#3 had a evaluation performed by staff other than a TC. Five of twelve laboratory testing personnel did not have an annual evaluation/competency for the years 2022 and 2023. -- 4 of 4 --

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of calibration verification records for the Stago STA Compact and Stago STA Compact Max coagulation systems since 3-30-21 and interview on 12-1- 21 at 2:30 p.m. with Technical Consultant (TC) #3 listed on the Centers for Medicare and Medicaid Services (CMS) Clinical Laboratory 209 personnel form, the laboratory failed to document, as performed, calibration verification for D-dimer and fibrinogen testing at least once every six months since 3-30-21. Findings include: Review of 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 -- calibration verification records for the Stago STA Compact and Stago STA Compact Max coagulation systems since 3-30-21 revealed no documentation of performance of calibration verification for D-dimer and fibrinogen testing. In an interview on 12-1-21 at 2:30 p.m., TC #3 confirmed calibration verification was not performed for D-dimer and fibrinogen testing during this time frame. THIS IS A REPEAT DEFICIENCY D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of the laboratory's method comparison records since 3-30-21 and confirmation by Technical Consultant (TC) #3 listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to evaluate the relationship between the results of complete blood count (CBC) testing performed using different methods at least twice a year. Findings include: Review of method comparison records since 3-30-21 and confirmation by TC #3 revealed that a comparison of results for CBC testing performed on the Sysmex XP-300 and the Sysmex XN-1000 analyzers was not documented as performed since 3-30-21. THIS IS A REPEAT DEFICIENCY D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: 1. Based on review of personnel records for individuals responsible for moderate complexity blood gas testing, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, and confirmation by Technical Consultant (TC) #2, a technical consultant failed to evaluate and document the performance of Testing Personnel (TP) #11 through #20 at least annually. Findings include: Review of personnel records since 3/30/31 revealed no documentation of annual competency evaluations performed by a technical consultant for TP #11 through #20, responsible for blood gas testing on the Radiometer ABL 80 Co-Ox Flex and Radiometer ABL 90 Flex analyzers. TC #2 confirmed there was no documentation of annual competency evaluations performed by a technical consultant for these testing personnel. 2. Based on review of personnel records for individuals responsible for moderate complexity oxyhemoglobin percent saturation testing, the CMS 209 personnel form, and confirmation by TC #2, a technical consultant failed to evaluate and document the performance of TP #21 through #25, listed on the CMS 209 personnel form, at least annually. Findings include: Review of personnel records since 3/30/31 revealed no documentation of annual competency evaluations performed by a technical consultant for Testing Personnel #21 through #25, responsible for oxyhemoglobin percent -- 2 of 3 -- saturation testing on the AVOXimeter 1000E analyzer. The annual competency evaluations available for these testing personnel on the day of the survey were performed by individuals not qualified as technical consultants. TC #2 confirmed there was no documentation of annual competency evaluations performed by a qualified technical consultant for these testing personnel. -- 3 of 3 --

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of calibration verification records for the Stago Sta-Compact coagulation system since the last survey on 9-15-16 and interview on 8-16-18 at 12:45 p.m. with Technical Consultant #3, listed on the Centers for Medicare and Medicaid Services (CMS) Clinical Laboratory 209 personnel form, the laboratory failed to document, as performed, calibration verification for D-dimer testing at least once every six months from 6-21-17 until 5-7-18 and for fibrinogen testing from 3-4-17 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 -- until 2-1-18. Findings include: Review of calibration verification records for the Stago Sta-Compact coagulation system since the last survey on 9-15-16 revealed no documentation of performance of calibration verification for D-dimer testing from 6- 21-17 until 5-7-18 and for fibrinogen testing from 3-4-17 until 2-1-18. In an interview on 8-16-18 at 12:45 p.m., Technical Consultant #3 confirmed calibration verification was not performed for D-dimer and fibrinogen testing during these time frames. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of the chemistry and blood gas procedure manual and laboratory records from last survey, 9/15/16 through 8/16/18, and confirmation from technical consultant and general supervisor at 1:30 pm on 8/16/18, the laboratory failed to evaluate the relationship between the results of different instruments performing the same testing at least twice a year. A system of acceptability should be established and evaluated between the test results. The following analyzers in chemistry and blood gas perform the same patient testing: Cobas e501 and Cobas e501 - chemistries Cobas 411 and Cobas 601(6000)- endocrinology testing Radiometer ABL 90 Flex and Radiometer 80 Co-Ox Flex - blood gases Findings include: Based on review of method comparison records since the last survey on 9-15-16 and confirmation by the Technical Consultant and General Supervisor Personnel revealed that a comparison of : 1. Chemistry results for the Cobas e501 #1 and Cobas e501 #2 was not documented as performed since 9-15-16. 2. Endocrinology results for the Cobas e411 and Cobas 601 (6000) was not documented as performed since 9-15-16. 3. Blood gas results for the Radiometer ABL 90 Flex and Radiometer 80 Co-Ox Flex was not documented as performed since 9-15-16 22079 Based on review of the laboratory's method comparison records since the last survey on 9-15-16 and confirmation by Cath Lab Testing Personnel #3, listed on the Cath Lab CMS 209 personnel form, the laboratory failed to evaluate the relationship between the results of hemoglobin oxygen saturation testing performed using different methods at least twice a year. Findings include: Review of method comparison records since the last survey on 9-15-16 and confirmation by Cath Lab Testing Personnel #3 revealed that a comparison of results for hemoglobin oxygen saturation performed on the Avox Systems Avoximeter 1000E analyzer and the Radiometer ABL 80 Flex and ABL 90 analyzers was not documented as performed since 9-15-16. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on review of personnel records since the last survey on 9-15-16, the Cath Lab CMS 209 personnel form, lack of documentation of annual evaluations by a technical consultant, and confirmation by Cath Lab Testing Personnel #3, a technical consultant failed to evaluate and document the performance of Cardiac Catheterization Laboratory (Cath Lab) Testing Personnel #1, #3, and #4, responsible for hemoglobin oxygen saturation testing, at least annually since 9-15-16. Findings include: Review of personnel records for Cath Lab Personnel #1, #3, and #4, listed on the Cath Lab CMS 209 personnel form as responsible for hemoglobin oxygen saturation testing, revealed no annual evaluations performed by a technical consultant for Cath Lab Testing Personnel #1, #3, and #4 since the last survey on 9-15-16. Cath Lab Testing Personnel #3 confirmed annual evaluations had not been performed by a technical consultant since 9-15-16. -- 3 of 3 --