Four Tech Laboratory Llc

Summary Statement of Deficiencies D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the College of American Association of Bioanalysts (AAB) proficiency testing (PT) records, interview with the technical consultants (TC), and testing personnel (TP); it was determined that the laboratory failed to attain an overall testing event score of at least 80 percent which is unsatisfactory performance for the Nonchemistry first event in 2022 (Q1-2022) for the coagulation Prothrombin Time analyte. The findings included: 1. On the date of the survey March 22, 2023, at approximately 12:0 p.m. based on review of the Prothrombin Time scores, the laboratory obtained for Q-1 2022 an overall score of 0% The results were as follow: PT-Q Overall score 0% Sample Reported Expected 1 33.7 4.8 - 27.13 2 13.8 2.2 - 11.42 3 13.7 7.7 - 11.25 4 24.0 5.0 - 19.81 5 14.4 5.2 - 12.3 2. The TC and TP affirmed on March 22, 2023, at approximately 12:30 p.m. that the laboratory obtained the PT scores in 1. 3. According to the laboratory testing declaration submitted on the day of the survey, the laboratory performed approximately 115 Prothrombin Time samples quarterly during the time the laboratory received unsatisfactory PT performance scores. 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. 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 -- This STANDARD is not met as evidenced by: Based on the lack of documentation, review of testing personnel competency assessment records, and interview with the technical consultant (TC) and testing personnel (TP) on March 22, 2023, as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to establish and follow written policies and procedures to assess the TP competency for the year 2021. Findings include: 1. Based on review of the laboratory's policies and procedure and competency evaluations' records the laboratory failed to follow written policies and procedures for competency assessment of the TP. 2. The laboratory fail to provide documentation of training and competency assessment for the TP performing Routine Chemistry and Hematology moderate complexity sample processing and testing at the laboratory for the year 2021. 4. This deficient practice was affirmed by interview with the TC and TP on March 22, 2023, at approximately 1:45 p.m. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of laboratory test records for seven (7) out of seven (7) randomly chosen patients from 11/15/2021 to 1/20/2023 and interviews with laboratory technical consultant (TC) and testing personnel (TP), the laboratory failed to include in the final report the identification of the personnel performing testing. The findings include: 1. The following patients reviewed at the time of the survey 3/22/2023 did not have the identification of the TP performing the tests: Date Pt# Test 01/15/2021 Pt # 1 Chemistry, CBC 12/22/2021 Pt # 2 CBC 02/17/2022 Pt # 3 PT 10/20/2022 Pt # 4 Chemistry, CBC 01/20/2023 Pt # 5 CBC, ESR, Chemistry 01/12/2023 PT # 6 PT 02 /18/2022 PT# 7 PT 2. The TC and TP affirmed on 3/22/2023 at approximately 1:30 p. m. of the aforementioned in 1 above. 3. Based on the stated annual test volume, the laboratory reported approximately 118,710 patients test results without identifying the TP performing the tests for the years 2021, 2022, and up to the time the survey took place. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(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 lack of documentation for competency assessments for the year 2021 and interview with the testing personnel; it was determined that the technical consultant /director failed to perform and document the performance evaluation of all testing -- 2 of 3 -- personnel and assuring that the staff maintained their competency to perform test procedures promptly, accurately, and proficiently. The findings included: see D5209. -- 3 of 3 --

Summary Statement of Deficiencies 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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Routine Chemistry constituting unsuccessful PT performance. (See D2096) 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 -- 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Sodium (Na), as follows: 2021 Q3 2022 Q1 Sodium 20% 60% Q1 = First testing event Q3 = Third testing event b. Failure to achieve satisfactory performance for the same analyte or test in two of three consecutive PT resulted in an initial unsuccessful performance for the analyte, Na. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, Na, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (see D2016 and D2096) -- 2 of 2 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory's reagent materials and interview with the laboratory's testing personnel (TP); it was determined that the laboratory failed to label reagents to indicate the opening, preparation, and expiration dates when such reagents are used. The findings included: 1. Based on the surveyor's observation during the laboratory tour on August 31, 2021 at approximately 11:40 a.m., the TP indicated that no opening, preparation, or expiration date labels were documented for all the reagents used in the laboratory. 2. The laboratory's TP affirmed in an interview conducted August 31, 2021 at approximately 11:45 a.m. that the reagents currently used to test patients' samples were not labeled with opening, preparation, and expiration dates. 3. Based on the laboratory's annual testing declaration submitted at the time of the survey, the laboratory analyzed approximately 70,389 samples annually D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. 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 -- This STANDARD is not met as evidenced by: Based on the surveyors' observation, examination of laboratory reagents, and interview with the technical supervisor (TS) and testing personnel (TP), it was determined that the laboratory failed to not use reagents when they have exceeded their expiration date. The findings included: 1. On the day of inspection, August 31, 2021 at approximately 11:30 a.m. the surveyor found the STAT stain used for blood cells manual differential stain Lot number 361 being used beyond its expiration date (07/2017). 2. The TP affirmed on 08/31/2021 at approximately 11:45 p.m. using STAT stain reagent beyond its expiration date. 3. Based on the laboratory's submitted testing declaration volume, the laboratory tests and reports approximately 18,308 Hematology samples which include blood cells manual differentials. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the lack of quality control (QC) documentation, observation of culture media used in the bacteriology section and interview with the technical supervisor (TS) and general supervisor (GS); it was determined that the laboratory failed to perform QC testing on all culture media. The findings included: 1. The laboratory did not check of sterility, ability to support growth, physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer of all the media used for cultures. 2. The laboratory must document all control procedures performed. 3. Based on the laboratory's annual declaration submitted at the time of the survey, the laboratory analyzed and reported 975 cultures which results cannot be assured. 4. The TS and GS confirmed on august 31, 2021 at approximately 1:00 p.m. that the laboratory failed to perform and document; check of sterility, ability to support growth, physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer of all the media used for cultures. D6178 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(4) Each individual performing high complexity testing must follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, lack of reagent labels on day of use, expiration date of reagents, quality control logs for culture media, and interview with the testing personnel and general supervisor, it was determined that the testing personnel performing high complexity testing did not follow the laboratory's -- 2 of 3 -- established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance. See D5414, D5417, and D5477. -- 3 of 3 --

Summary Statement of Deficiencies 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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Hematology constituting unsuccessful PT performance. (See D2130) 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 -- 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 CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Partial Thromboplastin time (PTT), resulting in an "initial" (first) unsuccessful performance. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, PTT, as follows: 2020 Q3 2021 Q1 PTT 60% 60% Q1 = First Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analyte, PTT. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, PTT, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2130) -- 2 of 2 --

Summary Statement of Deficiencies D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on the request for patient/test records and confirmation by the technical consultant, the laboratory failed to record the time patient samples were received. Findings include: a. The laboratory was unable to provide the time of specimen receipt for all patient samples choosen (sampling consisted of six random patients, for the period January 4, 2017 to June 11, 2018). b. The technical consultant confirmed (December 14, 2018, 11:00 A.M.) that the laboratory did not record the time of specimen receipt. 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 the review of temperature charts, reagent/control package inserts and interview with the technical consultant, the laboratory failed to store control material according to manufacturer's instructions. Findings include: a. The laboratory provided 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 -- the surveyor with a photocopy of the BIO-RAD Liquichek, Immunoassay Plus Control 1, 2, and 3 package insert (LOT 40951, 40952, and 40953, respectively, all lots have the expiry of 2019-10-31). All three controls has the manufacturer specifing storage temperature as between -20C to -70C. Controls are used in the Free Thyroxine test (FT4). b. The daily freezer temperature chart (for the above controls), the laboratory recorded 32 temperature readings (beginning at November 1,2018 through December 14, 2018). For the defined period, 3 days temperature were recorded as -20 C; the other 29 days had temperature recorded which were outside acceptable range (either -18C or -19C). c. The laboratory performs approximately 10 FT4 tests a month, even though they do not store the tests controls according to manufacturer's instructions. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on the discovery of expired vacutainer tubes and interview with the technical consultant, the laboratory failed to ensure that expired vacutainer tubes were not used. Findings included: a. During the Four Tech Laboratory LLC onsite CLIA recertification survey, discovered in the laboratory's supply area were a handful of BD Vacutainer tubes: Sodium Fluoride Potassium Oxolate 10mg/8mg, Lot #7100990, expiry 2018-08-31. b. The technical consultant confirmed (December 14, 2018, 11:20 A.M.) that the above grey top vacutainer tubes found were indeed expired and should not be used. c. The technical consultant and an owner of the laboratory stated that the laboratory does not run any tests off using grey tops; never the less, if a patient had Doctor's orders for a sendout test that requires collection be performed with a grey top vacutainer tube - there would be a chance that those expired tubes would be used. D5789 TEST RECORDS CFR(s): 493.1283(b) Records of patient testing including, if applicable, instrument printouts, must be retained. This STANDARD is not met as evidenced by: Based on the lack of documents and an interview with the technical consultant, the laboratory failed to retain testing records for a proficiency testing sample. Findins include: a. The laboratory has a policy to repeat hemoglobin (HGB) samples when they are either less than 11.0 g/dL or greater than 18.0 g/dL. b. The laboratory initially tested their American Association of Bioanalysts (AAB) hematology sample #4 for HGB on 10/26/2018 at 10:23:28 P.M. The test result was 6.3 g/dL. c. The testing person confirmed (December 14, 2018, 11:55 A.M.) that the above proficiency testing sample was repeat tested due to the low initial HGB value, but was unable to produce the testing records. d. From an owner of the laboratory, the laboratory performs approximately 125 Complete Blood Counts (CBC, which include a HGB test) per month, even though the above test record could not be found. -- 2 of 2 --

Summary Statement of Deficiencies 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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Routine Chemistry constituting unsuccessful PT performance. (See D2096) 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 -- 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Cholesterol, total (Chol, total), resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, Chol, total, as follows: 2018 Q1 2018 Q2 Chol, total 0% 60% Q1 = First Testing Event Q2 = Second Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analytes, Chol, total. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, Chol, total, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2096) -- 2 of 2 --