Crockett Medical Center

Summary Statement of Deficiencies D0000 An onsite survey conducted January 17th through January 19th 2024 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of proficiency testing records and interview with facility personnel, the laboratory director failed to attest to the routine integration of proficiency testing samples into the patient workload using the laboratory's routine methods for one of three Chemistry Miscellaneous events in 2023, one of three Chemistry core events in 2023, and one of three Hematology/Coagulation events in 2022. The findings included: 1.Based on review of the American Proficiency Institute attestation sheets, the following instructions were provided: "SIGNATURES REQUIRED - For all PT results, an attestation statement must be signed by testing personnel and the laboratory director and retained for a minimum of 2 years. Either the attestation worksheet or this online attestation statement may be used. Electronic signatures must have evidence that only the authorized person can utilize the signature." The following attestation sheets were not signed by the laboratory director: 2023 - Chemistry Miscellaneous, 1st event 2023 - Chemistry Core - 3rd event 2022 - Hematology/Coagulation 3rd event 2. In an interview at 15:14 hours on 1/ 17/24, the laboratory's Administrative Supervisor confirmed the attestations had not been signed by the laboratory director. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) 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 -- (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and interview with facility personnel, the laboratory failed to take

Summary Statement of Deficiencies D0000 An unannounced complaint investigation was conducted on 8/22/2023. The laboratory was in compliance with the Requirements for Laboratories found at 42 CFR part 493. Complaint TX00436561 was substantiated with standard deficiencies cited. 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 laboratory policy, laboratory temperature records, and confirmed in an interview, the laboratory failed to ensure the appropriate documentation of temperatures for the storage of blood products for transfusion for 10 of 36 weeks reviewed from December 2022 to August 2023. The findings included: 1. A review of the laboratory policy titled "Blood Bank Refrigerator Check" had the following instructions for the continuous temperature monitoring recording charts: "Blood bank recording charts shall be changed weekly." 2. Review of the laboratory blood bank continuous monitoring recording charts, from December 7, 2022, to August 16, 2023, had the following 10 instances where the temperature recording elapsed the weekly (7 days) change requirement causing the elapsed temperature recording to overlay previous temperature recordings: December 2022: Start: 12/7 /2022 at 12:45 - End 12/16/2022 at 07:14 10 days from the start date to the end date, end date included. Start: 12/16/2022 at 07:14 - End 12/25/2022 at 15:10 9 days from the start date to the end date, end date included. Start: 12/25/2022 at 15:10 - End: 1/4 /2023 at 07:30 10 days from the start date to the end date, end date included. January 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 -- 2023: Start: 1/11/2023 at 07:01 - End: 1/18/2023 at 08:50 8 days from the start date to the end date, end date included. Start: 1/18/2023 at 08:50 - End: 1/25/2023 at 17:50 8 days from the start date to the end date, end date included. February 2023: Start: 2/22 /2023 at 11:10 - End: 3/1/2023 at 16:50 8 days from the start date to the end date, end date included. March 2023: Start: 3/8/2023 at 18:00 - End 3/17/2023 at 09:05 10 days from the start date to the end date, end date included. Start: 3/22/2023 at 08:30 - End 3 /30/2023 at 07:50 9 days from the start date to the end date, end date included. April 2023: Start: 4/12/2023 at 07:25 - End 4/19/2023 at 13:00 8 days from the start date to the end date, end date included. May 2023: Start: 5/31/2023 at 08:00 - End 6/15/2023 at 1200 16 days from the start date to the end date, end date included. 3. In an interview on 8/22/2023 at 11:30 hours, in the laboratory, testing personnel (TP) 1 confirmed that the continuous temperature monitoring chart system had elapsed the weekly (7 day) change requirement. 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: I. Based on review of laboratory policy, laboratory document, laboratory temperature charts, and confirmed in interview, the laboratory failed to have a mechanism in place for the identification and correction of issues with the continuous monitoring system for three of seven days reviewed from 8/9/2023 to 8/16/2023. The findings included: 1. Review of the laboratory policy titled "Blood Storage Policy" had the following statements: "Per AABB Standards Packed Red Blood Cells (PRBC's) must be stored between 1 and 6 (degrees) C (Celsius) .... This refrigerator is monitored 24 hours a day by a temperature graph recorder and is checked every morning as well during daily maintenance procedures." 2. Review of the laboratory continuous monitoring chart system had the following three days where the graph was recording a temperature of 0 (degrees) C: Wednesday 8/9/2023 at 12:29 hours to Saturday 8/13 /2023 at approximately 4:00 hours. A review of the August 2023 form titled "Blood Bank Temp Log" had the following daily temperature documentation recorded by testing personnel for the chart system on days where the chart was recording 0 (degrees) C : 8/9/2023 - 4 (degrees) C 8/10/2023 - 4 (degrees) C 8/11/2023 - 4 (degrees) C 8/12/2023 - 4 (degrees) C 8/13/2023 - *recal 4 (degrees) C 3. In an interview on 3/22/2023 at 11:25 hours, in the laboratory, testing personnel (TP) 1 confirmed the discrepancy in the temperature recorded versus the temperature documented, and that the testing personnel had not documented the chart temperature appropriately. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced complaint investigation conducted March 6, 2023, and March 7, 2023, found the laboratory out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; Complaint # TX00446480 was substantiated with deficiencies cited. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on surveyor observations, document review, and interview with the Laboratory Director, the laboratory failed to verify accuracy, precision, reportable range, and patient normal ranges prior to performing patient testing on two of two OPTI-CCA blood gas analyzers. The findings included: 1. Based on surveyor observations in the laboratory at 13:44 hours on 3/6/2022, the laboratory used two OPTI-CCA TS2 blood gas analyzers for patient testing. The two analyzers were serial numbers OP6-005431 and OP6-001374. 2. Based on review of documentation, the laboratory began using the analyzers in the laboratory in June of 2022, nine months prior to the date of the investigation. 3. In an interview at 15:39 hours on 3/6/2023 via telephone, the Laboratory Director stated he noticed the analyzers did not have verification studies performed prior to patient use and had initiated the purchase of a new blood gas analyzer from a different manufacturer. 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 -- D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of laboratory personnel files, the Centers for Medicare and Medicaid (CMS) personnel form 209, and confirmed in an interview, the laboratory director failed to ensure that three of seven personnel had the appropriate documentation of training before testing patients' specimens. The findings include: 1. Review of laboratory personnel files included three travel testing persons (TP), listed on the CMS209, and their start dates: TP 3 - Start date of 12/20/2022 TP 4 - Start date of 1/16/2023 TP 5 - Start date of 1/26/2023 2. In an interview on 3/7/2023 at 10:25 hours, in the laboratory, the laboratory director confirmed that the documentation of training had not been performed before patient testing had occurred. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on a review of laboratory personnel files, the Centers for Medicare and Medicaid (CMS) personnel form 209, and confirmed in an interview, the laboratory failed to ensure that one of seven testing personnel met the qualification requirements of 493.1423 to perform moderate complexity testing. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of laboratory personnel files, the Centers for Medicare and Medicaid (CMS) personnel form 209, and confirmed in an interview, the laboratory failed to ensure that one of seven testing personnel had the educational documentation to meet the qualifications for moderate complexity testing personnel outlined at 493. 1423 (b). The findings include: 1. Review of laboratory personnel files did not include diplomas, degrees, or transcripts, that could be used for qualifying as a testing person, for testing person (TP) 3. Surveyor queried for TP 3's educational records on 3/6/2023 at 1520 hours. Email correspondence was provided on 3/7/2023 at 11:26 hours from the travel tech placement company stating TP 3 had 'no diploma on file'. No other documentation was provided. 2. In an interview on 3/7/2023 at 11:30 hours, in the laboratory, the laboratory director confirmed that the laboratory had not ensured that the educational documentation needed to qualify TP 3 as a moderate complexity testing person. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on September 12, 2022, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: 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 proficiency desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute proficiency testing records, the facility failed to 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 -- achieve successful performance (80% or greater) for the analyte Partial Thromboplastin Time (PTT) in four of four consecutive testing events in 2021 and 2022 resulting in unsuccessful performance. 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 proficiency desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, and American Proficiency Institute (API) proficiency testing records from 2021 and 2022, the laboratory failed to achieve a testing event score of satisfactory performance (80% or greater) for four consecutive testing events for the analyte Partial Thromboplastin Time (PTT). This is a subsequent failure to the non-initial proficiency testing failure identified on 2/11/2022. Findings include: 1. A review of the CASPER Report 155 listed the following scores for the API PT Program analyte PTT: 2021 Event 2: 40% 2021 Event 3: 60% 2022 Event 1: 60% 2022 Event 2: 60% 2. A desk review of the American Proficiency Institute (API) proficiency testing records from 2021 and 2022 confirmed that the laboratory received unsatisfactory consecutive scores for the analyte PTT in 2021 events 2 and 3, as well as 2022 events 1 and 2. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program for the analyte PTT. 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 proficiency desk review of the Certification and Survey Provider -- 2 of 3 -- Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program for the analyte PTT for four of four consecutive events from 2021 and 2022. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on May 11, 2022, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, and American Proficiency Institute (API) proficiency testing records from 2021 and 2022, 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 achieve satisfactory performance (80% or greater) for the analyte Partial Thromboplastin Time (APTT) in three out of three consecutive events, resulting in unsuccessful performance. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, and American Proficiency Institute (API) proficiency testing records from 2021 and 2022, the laboratory failed to achieve satisfactory performance (80% or greater) for the analyte Partial Thromboplastin Time (APTT) in three out of three consecutive events. The findings include: 1. A review of the CASPER report 155 lists a score of "40%" for the API Hematology 2nd Event, a score of "60%" for the API Hematology 3rd Event, and a score of 60% for the 1st event of 2022 for the analyte APTT. 2. A proficiency desk review of the API proficiency testing records from 2021 confirmed that the laboratory received unsatisfactory scores for APTT during the API Hematology 2nd and 3rd Event of 2021 and 1st event of 2022. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for analyte APTT. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency -- 2 of 3 -- Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for analyte APTT for three out of three events in 2021 and 2022. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 . Based on a proficiency testing desk review survey performed on February 9, 2022, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, and American Proficiency Institute (API) proficiency testing records from 2021, the laboratory failed to achieve 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 -- satisfactory performance (80% or greater) for the analyte Partial Thromboplastin Time (APTT) in two out of two consecutive events, resulting in unsuccessful performance. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, and American Proficiency Institute (API) proficiency testing records from 2021, and confirmed in interview, the laboratory failed to achieve satisfactory performance (80% or greater) for the analyte Partial Thromboplastin Time (APTT) in two out of two consecutive events. The findings include: 1. A review of the CASPER report 155 lists a score of "40%" for the API Hematology 2nd Event, and a score of "60%" for the API Hematology 3rd Event for the analyte APTT. 2. A proficiency desk review of the API proficiency testing records from 2021 confirmed that the laboratory received unsatisfactory scores for APTT during the API Hematology 2nd and 3rd Event. 3. In an interview on 2/10/2022 at 11:20 hours, in the break room, the laboratory manager confirmed the above. . 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for analyte APTT. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency -- 2 of 3 -- Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for analyte APTT for two out of two events in 2021. Refer to 2016 and 6000. . -- 3 of 3 --