Coal County General Hospital Inc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/07,08,09/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the chief executive officer, technical consultant #1, and the laboratory supervisor during an exit conference performed at the conclusion of the survey. 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 a review of records and interview with the technical consultant, 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 2 -- laboratory failed to perform calibration verification procedures at least once every six months for the Triage Meter Pro test system during the review period of 04/14/2023 through the current date. Findings include: (1) On 01/08/2025 at 10:45 am, the technical consultant stated the laboratory performed D-Dimer testing using the D- Dimer cartridges and the Triage Meter Pro; (2) A review of records from 0414/2023 through the current date identified no evidence the calibration verification procedures had been performed for the Triage Meter Pro test system between 04/14/2023 and 04 /18/2024. (3) The findings were reviewed with the technical consultant, who stated on 01/08/2025 at 10:45 am, the calibration verification procedures had not been performed every six months as stated above. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to perform QC (Quality Control) as stated in the IQCP (Individualized Quality Control Plan) for two of two test systems during the review period of January 2024 through the current date. Findings include: (1) On 01/09/2025 at 09:05 am, the technical consultant stated the following: (a) The Biomerieux Biofire analyzer was used to perform the Respiratory Panel and GI (Gastrointestinal) Panel testing; (b) An IQCP (Individualized Quality Control Plan) had been developed for each of the test systems. (2) A review of the QCP (Quality Control Plan) for each of the test systems identified positive and negative quality control materials were to be tested on a monthly basis; (3) A review of QC records from January 2024 through the current date identified QC testing had not been performed as stated in the QCP as follows: (a) Respiratory Panel - Not performed between 11/13/2024 and 01/02/2025 (b) GI Panel - Not performed between 11/14/2024 and 01/02/2025 (4) The records were reviewed with the technical consultant who stated on 01/09/2025at 09:35 am, QC had not been performed as stated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions: 493.803; D2016: Successful Participation 493.1407; D6000: Laboratory Director, Moderate Complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and proficiency testing Comparative Evaluation obtained from API (American Proficiency Institute) for the third 2023 and second 2024 events, the laboratory failed 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 -- to successfully participate in a proficiency testing program for the specialty of Hematology. Findings include: (1) The laboratory failed to achieve satisfactory performance for two of three consecutive testing events for the analyte PTT (Partial Thromboplastin Time). Refer to D2130. D2130 HEMATOLOGY 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 a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from API (American Proficiency Institute), the laboratory failed to achieve successful performance for the analyte PTT (Partial Thromboplastin Time) for two of three consecutive testing events. Findings include: (1) The laboratory received a score of 60% on the third 2023 event and a score of 60% on the second 2024 event. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from API (American Proficiency Institute), the laboratory failed to achieve satisfactory performance for the analyte PTT (Partial Thromboplastin Time) in two of three consecutive events. The laboratory failed to achieve a passing score of 80% for the third 2023 event and second 2024 event. 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 a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from API (American Proficiency Institute), the laboratory failed to achieve satisfactory performance for the -- 2 of 3 -- analyte PTT (Partial Thromboplastin Time) in two of three consecutive events. The laboratory failed to achieve a passing score of 80% for the thrid 2023 event and second 2024 event. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The rertification survey was performed on 03/20,21,22/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the chief executive officer, technical consultant, laboratory supervisor, and testing person #9 at the conclusion of the survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policies and procedures, and interview with the technical consultant and testing person #9, the laboratory failed to follow their written policy to assess the competency of the technical consultant and technical supervisor, based on the position responsibilities as listed in Subpart M, for one of one person serving as technical consultant and technical supervisor during the review period of June 2021 through the current date. Findings include: (1) On 03/21/2023 a review of the competency assessment policy identified competencies for the technical consultant and technical supervisor, based on the position responsibilities were to be performed annually; (2) A review of the Form CMS-209 and personnel records for competency assessments performed during the review period of June 2021 through the current identified competencies, based on job responsibilities, had not been performed as follows: (a) Technical Consultant - Not performed between 06/29/2021 and 03/21 /2023; (b) Technical Supervisor - Not performed between 06/29/2021 and 03/21/2023. (3) The findings were reviewed with the technical consultant and testing person #9. Both stated on 03/21/2023 at 02:41 pm, the competencies had not been performed for the positions as shown above. 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 -- D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, observation, and interview with the laboratory supervisor, the laboratory failed to ensure materials were stored as required for seven of seven months reviewed. Findings include: FREEZER #1 (1) On 03/22/2023 at at 01:30 pm, observation of the contents of the freezer identified the following materials: (a) One box containing one vial and one box containing five vials of Quidel Triage Total 5 Control 2, lot #C3901AN - the storage requirement as stated on the box was -20 degrees C (Centigrade) and colder; (b) One box containing five vials of Quidel Triage Total 5 Control 1, lot #C3896AN - the storage requirement as stated on the box was -20 degrees C (Centigrade) and colder. (2) A review of temperature records for seven months (August 2022 through February 2023) identified the documented temperatures were warmer than -20 degrees C for two of seven months as follows: (a) October 2022 - One of 31 temperatures were documented as warmer than -20 degrees C; (b) January 2023 - four of 31 temperatures were documented as warmer than -20 degrees C. (3) The records were reviewed with the laboratory supervisor who stated on 03/22/2023 at 01:40 pm, the materials were not being stored as required by the manufacturer. FREEZER #2 (1) On 03/22/2023 at at 01:30 pm, observation of the contents of the freezer identified the following materials: (a) Six boxes containing six vials each of Bio-Rad Liquichek Cardiac Markers Plus Ct controls, lot #87831 - the storage requirement as stated on the box was -20 to -70 degrees C; (b) Eight boxes containing six vials each of Bio-Rad Liquichek Cardiac Markers Plus Ct controls, lot #87833 - the storage requirement as stated on the box was -20 to -70 degrees C; (c) Four boxes containing six vials each of Bio-Rad Liquichek Cardiac Markers Plus Ct controls, lot #87841 - the storage requirement as stated on the box was -20 to -70 degrees C; (d) Four boxes containing six vials each of Bio-Rad Liquichek Cardiac Markers Plus Ct controls, lot #87843 - the storage requirement as stated on the box was -20 to -70 degrees C. (2) A review of temperature records for seven months (August 2022 through February 2023) identified the documented temperatures were warmer than -20 degrees C for six of seven months as follows: (a) August 2022 - 17 of 31 temperatures were documented as warmer than -20 degrees C; (b) September 2022 - Five of 30 temperatures were documented as warmer than -20 degrees C; (c) October 2022 - One of 31 temperatures were documented as warmer than -20 degrees C; (d)November 2022 - Two of 30 temperatures were documented as warmer than -20 degrees C; (e) December 2022 - Five of 31 temperatures were documented as warmer than -20 degrees C; (f) January 2023 - Five of 31 temperatures were documented as warmer than -20 degrees C. (3) The records were reviewed with the laboratory supervisor who stated on 03/22/2023 at 01:40 pm, the materials were not being stored as required by the manufacturer. FREEZER #3 (1) On 03/22/2023 at at 01:30 pm, observation of the contents of the freezer identified the following materials: (a) 12 boxes containing three bottles each of level one, level two, and level three control materials, lot #0150 - the storage requirement as stated on the box was -20 degrees C -- 2 of 4 -- and colder; (b) Two boxes of Vitros CKMB Calibrator, lot #3360 - the storage requirement as stated on the box was -20 degrees C and colder; (c) Two boxes containing six vials each of Bio-Rad Liquichek Specialty Immunoassay control level two, lot #64922 - the storage requirement as stated on the box was -20 to -70 degrees C; (d) Five boxes containing 12 vials each of Bio-Rad Immunoassay Plus control level one, lot #85301 - the storage requirement as stated on the box was -20 to -70 degrees C. (2) A review of temperature records for seven months (August 2022 through February 2023) identified the documented temperatures were warmer than -20 degrees C for seven of seven months as follows: (a) August 2022 - Nine of 31 temperatures were documented as warmer than -20 degrees C; (b) September 2022 - Two of 30 temperatures were documented as warmer than -20 degrees C; (c) October 2022 - 12 of 31 temperatures were documented as warmer than -20 degrees C; (d) November 2022 - Nine of 30 temperatures were documented as warmer than -20 degrees C; (e) December 2022 - Nine of 31 temperatures were documented as warmer than -20 degrees C; (f) January 2023 - Two of 31 temperatures were documented as warmer than -20 degrees C; (g) February 2023 - Five of 28 temperatures were documented as warmer than -20 degrees C. (3) The records were reviewed with the laboratory supervisor who stated on 03/22/2023 at 01:40 pm, the materials were not being stored as required by the manufacturer. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on a review of records, FDA database, and interview with the technical consultant, laboratory supervisor, and testing person #9, the laboratory failed to establish the performance specifications of analytical sensitivity and analytical specificity for eight of eight analytes not cleared or approved by the FDA. Findings include: (1) On 03/22/2023 at 01:00 pm, the technical consultant and laboratory supervisor stated Estradiol, Ferritin, Folate, FSH (Follicle Stimulating Hormone), LH (Luteinizing Hormone), Progesterone, Testosterone, and Troponin I testing were performed using the Ortho Vitros 7600XT analyzer; (2) A review of the classification of the analytes using the OrthoVitros 7600XT analyzer on the FDA (Food and Drug Administration) test classification database identified the database did not include a classification for the analytes/analyzer combination. This confirmed that the tests had not been approved/classified by the FDA; (3) Interview with the technical consultant, laboratory supervisor, and testing person #9 on 03/22/2023 at 02:30 pm, confirmed the following: (a) The laboratory originally began testing the above analytes in January 2020; (b) The performance specifications performed at that time did not include the establishment of analytical sensitivity and analytical specificity; (c) There was no documentation to prove the analytical sensitivity and analytical specificity had -- 3 of 4 -- been established to date. NOTE: D5423 was cited on the previous recertification survey performed on 06/22/2021. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to ensure units of blood were stored under appropriate conditions for six of 48 blood bank refrigerator temperature charts reviewed from 02/25/2022 through 01/18/2023. Findings include: (1) On 03/20/2023 at 10:40 am, the technical consultant stated units of packed red blood cells were stored in the blood bank refrigerator, with a recorder connected to it to continuously record the temperature on thermograph charts and monitored the temperature for a seven day period: (2) A review of 48 refrigerator charts dated from 02/25/2022 through 01/18/2023 identified six of 48 charts had not been changed by the seventh day as follows: (a) Chart #1 - The chart had been put into use on 03/25/2022 and removed on 04/02/2022 (eight days); (b) Chart #2 - The chart had been put into use on 04/15/2022 and removed on 04/23/2022 (eight days); (c) Chart #3 - The chart had been put into use on 04/23/2022 and removed on 05/02/2022 (nine days); (d) Chart #4 - The chart had been put into use on 09/09/2022 and removed on 09/21/2022 (13 days); (e) Chart #5 - The chart had been put into use on 09/21/2022 and removed on 09/29/2022 (eight days); (f) Chart #6 - The chart had been put into use on 01/18/2023 and removed on 01/26/2023 (eight days) (3) The charts were reviewed with the technical consultant who stated on 03/20 /2023 at 01:50 pm, the above charts had not been changed by the 7th day. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/21,22,23/2021. The laboratory was found out of compliance with the following CLIA regulation: 493.1489; D6168: Testing Personnel Qualifications The findings were reviewed with technical consultant /general supervisor #2 and general supervisor #1 at the conclusion of the survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policy, and interview with general supervisor #1, the laboratory failed to have a written technical consultant and general supervisor competency policy based on the position responsibilities as listed in Subpart M. Findings include: (1) On 06/21/2021 surveyor #2 reviewed the competency assessment policy. It did not include guidance for assessing the competency of the technical consultant and general supervisor; (2) Surveyor #2 then reviewed personnel records for competency assessments performed during 2020 and to date in 2021. There was no evidence of competencies performed for technical consultant #2, general supervisor #1, and general supervisor #2 based on their job responsibilities; (3) Surveyor #2 asked the laboratory manager if a written policy to evaluate the technical consultant, general supervisor #1, and general supervisor #2 based on job responsibilities was available. General supervisor #1 stated on 06/21/2021 at 09:50 am a policy had not been written and the above competencies had not been performed. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 and interview with general supervisor #1, the laboratory failed to ensure expired blood bank quality controls were not available for use for 1 of 6 days. Findings include: (1) On 06/21/2021 at 01:25 pm, general supervisor #1 stated to surveyor #1 Crossmatch testing was performed in the laboratory which included ABO Typing using the tube method; (2) On 06/22/2021, surveyor #2 reviewed quality control and patient testing records for testing performed from 04/07/2019 through 07 /11/2019 and identified an expired reagent had been used 1 of 6 days of testing reviewed as follows: (a) Immucor Anti-A,B lot #304020, expiration date 06/07/2019 had been used for patient testing on 06/11/2019. (3) Surveyor #2 reviewed the records with general supervisor #1 who stated on 06/22/2021 at 02:50 pm an expired reagent had been used as indicated above. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on a review of records, FDA database, and interview with general supervisor #1, the laboratory failed to establish the performance specifications of analytical sensitivity and analytical specificity for 9 of 9 new analytes not cleared or approved by the FDA. Findings include: (1) On 06/23/2021 at 11:00 am, general supervisor #1 stated to surveyor #1 Estradiol, Ferritin, Folate, FSH (Follicle Stimulating Hormone), LH (Luteinizing Hormone), Progesterone, Pro-BNP (B-Type Natriuretic Peptide), Testosterone, and Troponin I testing were performed using the Ortho Vitros 7600XT analyzer 01/2020; (2) Surveyor #1 attempted to verify the classification of the analytes using the Ortho Vitros 7600XT analyzer on the FDA (Food and Drug Administration) test classification database, since classification of test systems are performed by the FDA. The database did not include a classification for the analytes /analyzer combination (if a test is not included on the FDA site, then it did not go through the FDA approval process, which defaults the classification of the test as high complexity); (3) Surveyor #1 explained this to general supervisor #1 who contacted the manufacturer and confirmed this information with the manufacturer's representative. Therefore, the analytes tested on the Ortho Vitros 7600 XT were classified as LDT (laboratory developed tests), which are high complexity, and requires the performance specifications of accuracy, precision, reportable range, analytical sensitivity, analytical specificity, and reference intervals (normal values) be -- 2 of 6 -- established; (4) Surveyor #1 reviewed the implementation records for the analyzer. There was no evidence the analytical sensitivity and analytical specificity had been established for Estradiol, Ferritin, Folate, FSH, LH, Progesterone, Pro-BNP, Testosterone, and Troponin I; (5) Surveyor #1 reviewed the validation records with general supervisor #1 who stated on 06/23/2021 at 2:30 pm analytical sensitivity and analytical specificity had not been established because it was believed the entire test system had been FDA approved. 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 general supervisor #1, the laboratory failed to follow the manufacturer's instructions for performing annual maintenance procedures for the blood gas analyzer. Findings include: (1) On 06/21/2021 general supervisor #1 stated to surveyor #1 at 01:00 pm, Blood Gas (pH, pCO2, pO2) was performed on the Opti CCA analyzer; (2) On 06/22 /2021, surveyor #1 reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance log titled, "Appendix C Maintenance Log". The annual requirement was as follows: (a) Replace Peristaltic Pump (3) Surveyor #1 then reviewed maintenance records from January 2020 through May 2021. The annaul maintenance had not been documented as performed during the review period; (4) Surveyor #1 reviewed the findings with general supervisor #1 who stated on 06/22 /2021 at 01:40 pm the annual maintenance had not been documented as performed as identified above. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with general supervisor #1, the laboratory failed to perform control procedures each day of blood bank testing for 2 of 6 days of patient testing. Findings include: (1) On 06/21/2021 at 01:25 pm, general supervisor #1 stated to surveyor #1 the laboratory performed Crossmatch Testing, which consisted of ABO/Rh, Antibody Screen, and Compatibility testing (performed between the patient and red blood cell donor unit(s)) using the tube method; (2) On 06 /22/2021, surveyor #2 reviewed records for blood bank testing performed on 07/18 /2020, 07/20/2020, 10/08/2020, 12/06/2020, 12/28/2020, and 03/03/2021 and identified quality control had not been performed for 2 of 6 days when patient Type and Screen or Crossmatch testing had been performed as follows: (a) Patient #1 - A Type and Screen was performed on 10/08/2020; (b) Patient #2 - A Type and Screen -- 3 of 6 -- and Crossmatch was performed on 03/03/2021. (3) Surveyor #2 reviewed the records with general supervisor #2. On 06/22/2021 at 04:05 pm, general supervisor stated quality control had not been performed as indicated above. 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 a review of records and interview with general supervisor #1, the laboratory failed to have a system that twice a year evaluated and defined the relationship between test results using different analyzers. Findings include: (1) On 06/23/2021 at 09:20 am, general supervisor #1 stated the following to surveyor #1: (a) The laboratory began using the Sysmex XN 550 analyzer to perform CBC (Complete Blood Count) testing as the primary analyzer 02/2020; (b) The Beckman Coulter AcT Diff 2 analyzer was used as the back-up analyzer. (2) Surveyor #1 asked general supervisor #1 if the relationship between the test results using the two different analyzers had been evaluated at least twice annually in 2020 and to date in 2021. General supervisor #1 stated on 06/23/2021 at 09:45 am the test results between the two analyzers had been compared when the Sysmex XN 550 analyzer had been implemented 02/2020, but the relationship between the analyzers had not been evaluated since then. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records and interview with general supervisor #1, the laboratory failed to have a policy for monitoring the effectiveness of their IQCP for 1 of 1 test systems. Findings include: (1) On 06/22/2021 at 04:00 pm, general supervisor #1 stated the following to surveyor #1: (a) Rhinovirus, Influenza A, AHI, AHI-2009, A1H3, Influenza B, Mycoplasma pneumoniae, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Respiratory Syncytial Virus, and SARS CoV-2, testing were performed using the Diagnostic Biomerieux BioFire analyzer; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) Surveyor #1 reviewed the IQCP (dated as approved on 07/29 /2020). The QA (Quality Assessment) portion of the IQCP did not include a schedule for evaluating the QCP (Quality Control Plan) to ensure it continued to provide accurate and reliable results; (3) Surveyor #1 reviewed the records with general supervisor #1, and asked if, in addition to the ongoing monitoring, the QA plan addressed how the laboratory will evaluate the QCP, including the frequency of the -- 4 of 6 -- reviews. General supervisor #1 stated on 06/22/2021 at 04:40 pm, the QA plan did not include an evaluation of the QCP, and the frequency of the reviews. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on a review of records and interview with general supervisor #1, the laboratory failed to ensure testing personnel were qualified to perform high complexity testing. Findings include: (1) The laboratory failed to ensure that each person performing high complexity chemistry testing was qualified. Refer to D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) 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 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; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and -- 5 of 6 -- storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on a review of records and interview with general supervisor #1, the laboratory failed to ensure that each person performing high complexity testing was qualified for 3 of 13 persons. Findings include: (1) On 06/23/2021 at 11:00 am, general supervisor #1 stated to surveyor #1 Estradiol, Ferritin, Folate, FSH (Follicle Stimulating Hormone), LH (Luteinizing Hormone), Progesterone, Pro-BNP (B-Type Natriuretic Peptide), Testosterone, and Troponin I testing were performed using the Ortho Vitros 7600XT analyzer 01/2020; (2) Surveyor #1 attempted to verify the classification of the analytes using the Ortho Vitros 7600XT analyzer on the FDA (Food and Drug Administration) test classification database, since classification of test systems are performed by the FDA. The database did not include a classification for the analytes /analyzer combination (if a test is not included on the FDA site, then it did not go through the FDA approval process, which defaults the classification of the test as high complexity); (3) Surveyor #1 explained this to general supervisor #1 who contacted the manufacturer and confirmed this information with the manufacturer's representative. Therefore, the analytes tested on the Ortho Vitros 7600 XT were classified as LDT (laboratory developed tests), which are high complexity; (4) On 06 /23/2021, surveyor #2 reviewed the Laboratory Personnel Report (Form CMS-209) that had been completed by the laboratory prior to the survey. General supervisor #1 stated 11:00 am to surveyor #2 that 9 of 13 testing persons were trained to perform chemistry testing on the Ortho Vitros 7600XT analyzer; (4) Surveyor #2 then reviewed personnel education and training records. There was no evidence that testing person #7, testing person #11, and testing person #13 had the qualifications to perform high complexity testing. The only education records contained in the files were a copy of a high school diploma for each person. The documentation in the training record verified that testing person #7, testing person #11, and testing person #13 had been trained to perform chemistry testing on the Ortho Vitros 7600XT analyzer; (5) Surveyor #2 reviewed the records with general supervisor #1 who stated on 06/23 /2021 at 3:30 pm, 3 of 13 testing persons did not meet the education requirement to perform high complexity testing as indicated above. -- 6 of 6 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/03/18 through 12/07/18. The laboratory was found to be in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory supervisor, general supervisor #4, general supervisor #5, laboratory director, chief executive officer, and chief operating officer 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 ensure proficiency testing attestation statements had been signed by the laboratory director or designee. Findings include: (1) On the first day of the survey, the surveyor reviewed 2017 and 2018 proficiency testing records. The following was identified for 2 of 20 testing events: (a) J-C 2017 Transfusion Medicine Event (i) The attestation was not signed by the laboratory director or designee; (b) Second 2018 Microbiology Event (i) The attestation was not signed by the laboratory director or designee. (2) The findings were reviewed with the laboratory supervisor who stated the attestations had not been signed as indicated above. 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 -- 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 perform a technical consultant competency based on the position responsibilities as listed in Subpart M. Findings include: (1) On the first day of the survey, the surveyor reviewed personnel records for competency assessments performed during 2017 and 2018. There was no evidence a technical consultant competency, based on their job responsibilities had been performed; (2) The surveyor asked the laboratory supervisor if a technical consultant competency based on job responsibilities had been performed. The laboratory supervisor stated a technical consultant competency based on job responsibilities 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: BIASES (1) On the first day of the survey, the surveyor reviewed 2017 and 2018 proficiency testing records. The following biases were identified (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) Second 2017 Chemistry Core Event (i) Troponin I - 3 of 5 results exhibited a positive bias (aa) Sample CH-06- SDI of 2.6 (bb) Sample CH-08 - SDI of 2.3 (cc) Sample CH-09 - SDI of 3.3 (b) Third 2017 Chemistry Core Event (i) Gentamicin - 3 of 5 results exhibited a negative bias (aa) Sample CH-12- SDI of -2.4 (bb) Sample CH-13 - SDI of -2.8 (cc) Sample CH-14 - SDI of -3.3 (c) Second 2018 Chemistry Core Event (i) Lactic Acid - 3 of 5 results exhibited a negative bias (aa) Sample CH-06- SDI of -2.4 (bb) Sample CH-07 - SDI of -3.9 (cc) Sample CH-10 - SDI of -3.3 (d) Third 2018 Chemistry Core Event (i) Total Protein - 3 of 5 results exhibited a negative bias (aa) Sample CH-12- SDI of -2.3 (bb) Sample CH-14 - SDI of -2.3 (cc) Sample CH-15 - SDI of -2.1 (ii) Lactic Acid - 3 of 5 results exhibited a positive bias (aa) Sample CH-12 - SDI of 2.6 (bb) Sample CH-14 - SDI of 2.0 (cc) Sample CH-15 - SDI of 3.0 (iii) Alcohol - 3 of 5 results exhibited a negative bias (aa) Sample ALC-11 - SDI of -4.0 (bb) Sample ALC-12 - SDI of -2.3 (cc) Sample ALC- 14 - SDI of -2.4 (dd) Sample ALC-15 - SDI of -2.6 (2) The surveyor could not locate evidence in the records proving the biases had been identified and addressed; (3) The records were reviewed with the laboratory supervisor who stated the biases had not been addressed. FAILURES (1) During the review of proficiency testing records, the surveyor identified the following failures in which there was no evidence of