Hazard Arh Regional Medical Center

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 verified with the proficiency testing company. The laboratory was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER)-0155 Individual Laboratory Profile Report and American Proficiency Institute (API) proficiency testing 2023 records (3rd event) and 2024 records (1st event and 2nd event), the laboratory failed to successfully participate in a proficiency testing program. The laboratory failed to successfully participate in the subspecialty of Routine Chemistry for the Partial Pressure of Carbon Dioxide (PCO2) Blood Gas and Potential of Hydrogen (PH) Blood Gas for three of three testing events. Refer to 2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 Individual Laboratory Profile Report and American Proficiency Institute (API) 2023 records (3rd event) and 2024 records (1st event and 2nd event), the laboratory failed to achieve satisfactory performance (80% or greater) for 3 of 3 consecutive testing events in Routine Chemistry for Partial Pressure of Carbon Dioxide (PCO2) Blood Gas, and Potential of Hydrogen (PH) Blood Gas. 1. Review of the CASPER-0155 Individual Laboratory Profile Report revealed the following: Routine Chemistry 2023- 3rd Event Laboratory received an unsatisfactory score of 0% for PCO2 Blood Gas. Routine Chemistry 2024- 1st Event Laboratory received an unsatisfactory score of 0% for PCO2 Blood Gas. Routine Chemistry 2024- 2nd Event Laboratory received an unsatisfactory score of 60% for PCO2 Blood Gas. Routine Chemistry 2023- 3rd Event Laboratory received an unsatisfactory score of 0% for PH Blood Gas. Routine Chemistry 2024- 1st Event Laboratory received an unsatisfactory score of 0% for PH Blood Gas. Routine Chemistry 2024- 2nd Event Laboratory received an unsatisfactory score of 60% for PH Blood Gas. 2. A proficiency testing desk review from API 2023 and 2024 proficiency testing records confirmed the above findings. 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 proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 Individual Laboratory Report and American Proficiency Institute (API) 2023 (3rd event) and 2024 (1st event and 2nd event) records, it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services to ensure successful PT participation of Partial Pressure of Carbon Dioxide (PCO2) Blood Gas and Potential of Hydrogen (PH) Blood Gas testing during 3 of 3 testing events. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- 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 proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 Individual Laboratory Report and American Proficiency Institute (API) 2023 (3rd event) and 2024 (1st event and 2nd event) records, the laboratory director failed to ensure that the proficiency testing samples were tested as required under Subpart H during 3 of 3 testing events. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 03/26/2024 and concluded on 03/27/2024. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. 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 policy review, document review, and confirmed in staff interview; the laboratory failed to retain documentation of calibration for 1 of 54 chemistry test methods for 4 of 4 required calibration events in 2022 and 2023. Findings included: A review of a facility policy titled "Osmolality (Advanced Instruments Model 3320 Micro-Osmometer Osmolality)," adopted in 09/2018, revealed, "CALIBRATION: Re- calibration will need to be performed every six months." A review of calibration records for performance of osmolality revealed a lack of required documentation for 4 of 4 required calibration events in 2022 and 2023. During an interview on 3/27/2024 at 11:15 AM, Testing Personnel #4 stated osmolality calibration records were not printed off at the time of performance and that, because the instrument only retained results in memory for the last 1000 cycles, the calibration records could not be retrieved. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance 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 -- (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on policy review, document review and confirmed in staff interview; the laboratory failed to perform a self-evaluation of 3 of 11 proficiency testing results from 01/25/2022 to 03/26/2024 that were returned as "Not Graded" by the proficiency testing provider because of a lack of required level of agreement within the test method peer group. Findings included: A review of a facility policy titled, "Proficiency Testing," adopted in 12/96 and last reviewed in 02/20, revealed, "4. Ungraded proficiency results are evaluated, whether from lack of consensus, less than 20 participants, results submitted after the cut-off date, results not submitted, or incorrect testing information recorded" and "5. For lack of consensus or less than 20 participants, the results are reviewed against the findings of the proficiency testing service. If the results are comparable with the majority of the other participants the results are accepted as being valid. If not the test(s) are repeated, slides reviewed with other testing personnel for consensus, Director review and other steps as deemed necessary by the Director." A review of an American Proficiency Institute (API) report titled, "Proficiency Testing Performance Evaluation" for the "2023 Hematology /Coagulation - 1st Event," signed by the Lab Director or designee on 04/18/2023, revealed the laboratory failed to notate the ungraded analyte/sample on the performance evaluation page or a participant summary sheet. A review of an API report titled, "Comparative Evaluation 2023 Hematology/Coagulation - 1st Event" revealed the "Body Fluid Crystals" for sample "CYS-02" was not graded. Further review of the report revealed the "Body Fluid Microscopy" for sample "BFM-02" was not graded. A review of an API report titled, "Proficiency Testing Performance Evaluation" for the "2023 Hematology/Coagulation - 3rd Event," signed by the Lab Director or designee on 12/20/2023, revealed the laboratory failed to notate the ungraded analyte/sample on the performance evaluation page or a participant summary sheet. A review of an API report titled, "Comparative Evaluation 2023 Hematology/Coagulation - 3rd Event" revealed the "PMN (CSF/body fluid) (%)" for sample "BFL-04" was not graded. During an interview on 03/26/2024 at 12:45 PM, Technical Supervisor #2 confirmed the above findings. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on policy review, document review and confirmed in staff interview; a technical supervisor failed to perform annual competency assessments for performance of arterial blood gases for 28 (respiratory therapy staff) of 28 testing personnel in 2022. Findings included: A review of a facility policy titled, "Assessing Job Performance," adopted in 12/93 and last reviewed in 02/18, revealed under a "B. -- 2 of 3 -- Competencies" section, "c. Technical Staff Performing Non-Waived Testing; i. Competencies for technical staff reporting non-waived testing is performed at least semi-annually the first year and yearly thereafter" and "c. iv. The laboratory director has delegated competency assessments to the laboratory administrative director and the senior medical technologists who possess the educational requirements to function [as] technical and/or general supervisors in the clinical laboratory and for blood gas analysis performed by nursing and cardiopulmonary staff." A review of competency assessment records for the performance of arterial blood gases revealed a lack of required documentation for 28 respiratory therapy testing personnel in 2022. During an interview on 03/26/2024 at 3:45 PM, Technical Supervisor #2 confirmed the above findings. -- 3 of 3 --

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 verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 proficiency testing (PT) desk review of the Certification and Survey 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 -- Provider Enhanced Reporting (CASPER)-0155 Individual Laboratory Profile Report and American Proficiency Institute (API) 2023 (3rd event) and 2024 (1st event) records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Routine Chemistry for the Partial Pressure of Carbon Dioxide (PCO2) Blood Gas, Partial Pressure of Oxygen (PO2) Blood Gas, and Potential of Hydrogen (PH) Blood Gas. (Refer to 2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 Individual Laboratory Profile Report and American Proficiency Institute (API) 2023 (3rd event) and 2024 (1st event) records, the laboratory failed to achieve satisfactory performance (80% or greater) for two (2) of 2 (two) consecutive testing events in the specialty of Routine Chemistry for Partial Pressure of Carbon Dioxide (PCO2) Blood Gas, Partial Pressure of Oxygen (PO2) Blood Gas, and Potential of Hydrogen (PH) Blood Gas. 1. A Review of the CASPER-0155 Individual Laboratory Profile Report revealed the following: Routine Chemistry 2023- 3rd Event Laboratory received an unsatisfactory score of 0% for PCO2 Blood Gas. Routine Chemistry 2024- 1st Event Laboratory received an unsatisfactory score of 0% for PCO2 Blood Gas. Routine Chemistry 2023- 3rd Event Laboratory received an unsatisfactory score of 0% for PO2 Blood Gas. Routine Chemistry 2024- 1st Event Laboratory received an unsatisfactory score of 0% for PO2 Blood Gas. Routine Chemistry 2023- 3rd Event Laboratory received an unsatisfactory score of 0% for PH Blood Gas. Routine Chemistry 2024- 1st Event Laboratory received an unsatisfactory score of 0% for PH Blood Gas. 2. A review of API PT records from 2023-2024 confirmed the above findings. 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 proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 Individual Laboratory Profile Report and American Proficiency Institute (API) 2023 (3rd event) and 2024 (1st event) records, the laboratory director failed to provide overall management and direction of the laboratory services. (Refer to D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 2 of 3 -- 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 proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 Individual Laboratory Report and American Proficiency Institute (API) 2023 (3rd event) and 2024 (1st event) records, the laboratory director failed to ensure successful participation in an HHS approved PT program. (Refer to D2096) -- 3 of 3 --

Summary Statement of Deficiencies D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews, the laboratory failed to establish policies and procedures for the maintenance and verification of the staining process (refer to D5403); failed to establish written policies and procedures for prevention of cross-contamination (refer to D5619); failed to establish written policies and procedures for the evaluation of three of three annual statistics (refer to D5629); failed to establish written policies and procedures for the establishment of individual workload limits and failed to reassess workload limits at least every six months (refer to D5633 and D5637); failed to establish written policies and procedures to ensure that workload limits would be prorated when examining slides in less than eight hours (refer to D5641); failed to establish written policies and procedures to ensure the laboratory maintained records of the total number of slides examined per 24-hour period and the hours spent examining slides (refer to D5645); failed to establish written policies and procedures to document the workload limit (refer to D5647); failed to establish written policies and procedures to ensure unsatisfactory slide preparations were identified and reported as unsatisfactory (refer to D5655) and failed to establish written policies and procedures for corrected final reports (refer to D5659). D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of preanalytic quality assessment records and interview with the Laboratory Director/Technical Supervisor #1, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the preanalytic systems. The laboratory failed to document preanalytic quality assessment activities during 2020, 2021 and to the date of the survey in 2022. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for an ongoing program to monitor, assess and correct problems identified in the preanalytic laboratory systems. 2. The Survey Team requested and the laboratory failed to provide documentation of preanalytic laboratory quality assessment activities during 2020, 2021 and to the date of the survey in 2022. 3. During an interview on November 16, 2022 at 9:10 AM, the Laboratory Director /Technical Supervisor #1 confirmed these findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 On 01-24-2022 and 01-25-2022, this facility was surveyed and found to be in compliance with the laboratory requirements of 42 CFR Part 493 with no deficiencies. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --