Pilgrim Medical Center Inc

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyor observation of the laboratory reagents, refrigerator, water dispenser and interview with the Testing Personnel (TP), the laboratory failed to ensure protection from biohazardous materials from 8/2/23 to 10/1/25. The finding includes: 1. The office water dispenser was located in an area where laboratory testing was performed. 2. The TP #1 as listed on the CMS 209 form confirmed on 10/1/25 at 11: 15 am, the laboratory did not ensure protection from biohazardous material. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Quality Control (QC) and interview with the Testing Personnel (TP), the laboratory failed to have a QC policy for Rhesus factor (Rh) testing performed with the Immucor Inc Anti-D Tube method from 8/2/23 to 10/1/25. The finding includes: 1. The laboratory used Panoscreen vials 1, 2 and 3 as QC. 2. There was no policy on how to use the above mentioned QC. 3. 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 -- There was no policy on how to document and monitor the above mentioned QC. 4. TP #1 as listed on the CMS form 209 confirmed on 10/1/25 at 10:55 am, the laboratory did not have a QC policy for Rh testing. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on the lack of Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to document QC for Rhesus factor (Rh) Immucor Inc Anti-D Tube method on each day of patient testing from 8/2/23 to 10/1/25. The finding includes: 1. There was no documented evidence TP performed QC for Rh tests on each day of patient testing. 2. Approximately 5000 patient tests were performed and reported annually. 3. TP #1 as listed on the CMS 209 form confirmed on 10/1/25 at 11:35 am, the laboratory did not perform daily QC for Rh tests. 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. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory did not establish a Quality Control Verification (QCV) procedure for verifying new lots of QC used for Rhesus factor (Rh) tests from 8/2/23 to 10/1/25. The findings include: 1. The laboratory did not establish a procedure for performing QCV on new lots of QC material that included the frequency, acceptability and rejection criteria. 2. TP #1 listed on the CMS 209 form confirmed on 10/1/25 at 11:10 am, the laboratory did not establish a detailed QCV procedure. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Quality Control (QC) material and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure a Quality Control (QC) and Quality Assurance (QA) program were established and maintained to assure the quality of laboratory services from 8/2/23 to 10/1/25. The finding includes: 1. The laboratory failed to establish a QC policy for Rhesus factor (Rh) testing. Cross refer D5401. 2. The laboratory did not perform QC for Rhesus factor (Rh) on each day of patient testing. Cross refer D5449. 3. QC -- 2 of 4 -- material was not verified before use. Cross refer D5469. 4. The laboratory did not establish a Quality Control Verification (QCV) procedure for verifying new lots of QC used for Rhesus factor (Rh) tests. Cross refer D5791. 5. TP #1 listed on CMS 209 form confirmed on 10/1/25 at 11:10 am, the QA and QC programs were not established and maintained. 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 surveyor review of the Testing Personnel (TP) files and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure Testing Personnel were qualified to perform Rhesus factor (Rh) testing from January 2025 to 10/1/25. The finding includes: 1. Surveyor review of TP files revealed that five out of five TP listed on the CMS 209 form did not meet the academic requirements to qualify them to perform Rh testing. 2. The TP #1 listed on CMS form 209 confirmed on 10/1/25 at 11:30 am, all TP did not meet the academic requirements to perform Rh testing.. 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 (b)(2)(i) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(2)(ii) Be qualified under the requirements of 493.1443(b)(3) or 493.1449(c)(4) or (5); or (b)(3)(i) Have earned an associate degree in a laboratory science or medical laboratory technology from an accredited institution or (b)(3)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes (b)(3)(ii) (A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either (b)(3)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(3)(ii)(A)(2) 24 semester hours of science courses that include (b)(3)(ii)(A)(2)(i) 6 semester hours of chemistry; (b)(3)(ii)(A)(2)(ii) 6 semester hours of biology; and (b)(3)(ii)(A)(2)(iii) 12 semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(3)(ii)(B) Have laboratory training that includes: (b)(3)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES or the CAAHEP (this training may be included in the 60 semester hours listed in paragraph (b)(3)(ii)(A) of this section); or (b)(3)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing; or (b)(4) Successful completion of an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and having held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(5) Notwithstanding any other provision of this section, an individual is considered qualified as a high complexity testing personnel under this section if they were qualified and serving as a high complexity testing personnel in a CLIA-certified -- 3 of 4 -- laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. (b)(6) For blood gas analysis (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3), (4), or (5) of this section; or (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. (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (f) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on surveyor review of the Testing Personnel (TP) files and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure Testing Personnel were qualified to perform Rhesus factor (Rh) testing from January 2025 to 10/1/25. The finding includes: 1. Surveyor review of TP files revealed that five out of five TP listed on the CMS 209 form did not meet the academic requirements to qualify them to perform high complexity testing. 2. The TP #1 listed on CMS form 209 confirmed on 10/1/25 at 11:30 am, all TP did not meet the academic requirements to perform high complexity testing. -- 4 of 4 --

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 an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of 80% or more for Endocrinology tests performed with the Wisconsin State Lab of Hygiene Proficiency Testing (WSLHPT) . The finding includes: 1) The laboratory scored 0% for Beta-Human Chorionic Gonadotropin (B-hCG) for the 1st event - 2023 with WSLHPT. 2) The laboratory scored 0% for B-hCG for the 2nd event- 2023 with WSLHPT. D2100 ENDOCRINOLOGY 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 -- CFR(s): 493.843(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing provider reports, the laboratory failed to participate in Endocrinology Beta- Human Chorionic Gonadotropin (B-hCG) events 1 and 2, 2023 with Wisconsin State Lab of Hygiene Proficiency Testing (WSLHPT). D2107 ENDOCRINOLOGY CFR(s): 493.843(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 an office review of the CASPER reports 153 and 155 and Proficiency Testing provider reports, the laboratory failed to achieve a score of 80% for Endocrinology tests. The finding includes: 1) The laboratory scored 0% for Beta- Human Chorionic Gonadotropin (B-hCG) for the 1st event - 2023 with Wisconsin State Lab of Hygiene Proficiency Testing (WSLHPT). 2) The laboratory scored 0% for B-hCG for the 2nd event- 2023 with WSLHPT. D2154 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(b) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to attain an overall testing event score of at least 100 percent for D (Rho) typing prformed the findings include. 1. The laboratory scored 80% for D (Rho) Typing event 3, 2022 with American Association of Bioanalysts (AAB). 2. The laboratory scored 0% for D (Rho) Typing event 2, 2023 with AAB. D2155 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(c) -- 2 of 3 -- Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing provider reports, the laboratory failed to participate in ABO and RHo(D) Groups, D (Rho) Typing with American Association of Bioanalysts (AAB) in event 2, 2023. 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 an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the laboratory director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys are performed satisfactorily and compliance with the CLIA regulations are maintained. -- 3 of 3 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to enroll in an approved PT program for Total Beta-Human chorionic gonadotropin (hCG) tests from December 2022 to the date of survey. The TP confirmed on 8/2/23 at 1:40 pm the laboratory was not enrolled in PT for Total beta-hCG tests. 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 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 -- 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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to have work and attestation records for all American Associates of Bioanlalysts (AAB) PT events for Endocrinology, Immunology, Rhesus (Rh) factor, and Serology tests in the calendar years 2023, 2022 and 2021. The findings include: 1. There were no work or attestation records for all PT events in the calendar years 2023, 2022 and 2021 2. The TP confirmed on 8/2/23 at 1:35 pm work and attestation records were not available for PT events as mentioned above. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), and interview with the Testing Personnel (TP), the laboratory failed to have a procedure for Quality control verification (QVC) for Endocrinology, Immunology, Rhesus (Rh) factor, and Serology testing and six month correlation studies for Endocrinology testing from 6/08 /21 to the date of survey. The TP confirmed on 8/2/23 at 2:30 pm that the laboratory failed to have the above mentioned procedures. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of the i-Stat Operators Manual (OM) and interview with the Testing Personnel (TP) the laboratory failed to OM From December 2023 to the date of survey. the findings include: 1) OM stating in "Quality Control" "daily procedures", "Verify the performance of each handheld in the i-STAT System using the internal or external Electronic Simulator every 24 hours of use," 2) There was no documented evidence the aforementioned procedure was performed. 3) The TP confirmed on 8/2/23 at 1:00 pm that the laboratory did not follow the OM. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations -- 2 of 6 -- 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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with Testing Personnel (TP), the laboratory failed to perform and document two levels of external controls on each day of patient testing for Total Beta-Human chorionic gonadotropin (hCG) run on the i-Stat analyzer from December 2022 to the date of the survey. The findings include: 1. The laboratory reported Total Beta-hCG results but there was no documented evidence that QC was performed every day of patient testing. 2. The laboratory performed approximately 4 Total Beta-hCG tests weekly. 3. The TP confirmed on 8/2/23 at 2:20 pm that two levels of QC were not run each day of patient testing. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to verify commercial QC material with each new lot and/or shipment of QC used for Endocrinology, Immunology, Rhesus (Rh) factor, and Serology tests performed on Abbott i-Stat, Wampole Impact RPR, Immuncor Rh, and ASI Rubella test systems on the date of survey. The finding includes: 1. There was no documented evidence that QC was verified before being put into use. 2. The TC confirmed on 8/2/23 at 2:20 pm that the QC material was not verified before putting in use. 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. -- 3 of 6 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual the lack of a correlation study and interview with the Testing Personnel (TP), the laboratory failed to perform correlation studies for Endocrinology tests performed on the i-Stat analyzers twice per year in the date of survey. The finding includes: 1. TP stated they "did not know a correlation study was needed" for instrument to instrument comparison of the two i-Stat analyzers. 2. The TP confirmed on 8/2/23 at 1:00 pm that the laboratory did not perform a correlation study twice a year. 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 surveyor review of the Laboratory records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to provide overall management and direction to the laboratory from 6/8/21 to the date of survey. The findings include: 1. The LD failed to ensure that Performance Specifications procedures were adequate. Cross refer 6013. 2. The LD failed to ensure that Proficiency Testing samples were tested. Cross refer 6016. 3. The LD failed to ensure that all PT results received were reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Quality Control Binder (QCB) and interview with the Testing Personnel (TP), the laboratory failed to follow their PM policy for "Quality Assurance Concurrent Testing using Anti D, Rh-Hr" for Rhesus (Rh) factor tests ran with Rh Immucor reagents from February 2019 to the date of survey. The finding includes: 1) The PM stated "When Changing lot numbers: Test old and new lots concurrently against respective quality control cells A2 (known as Rh negative) and Hemantigen (Known as positive). In addition, test a random Rh- negative patient against both lots. Reactivity should be the same." 2) The aforementioned procedure was last performed 2/2/19. The old lots are as follows: a) A2 Cell Lot number 112851 expired 2/8/19 b) Hematantigen lot number 16710 expired 2/8/19 3) The current lots are as follows: a) A2 Cell Lot number 112914 expires 6/25/21 b) Hematantigen lot number 16710 expires 6/25/21 4) Approximately 5,625 patients where run and reported. 5) The TP #1 on CMS form 209 confirmed on 6 /8//21 at 11:05 am the above mentioned procedure was not followed. 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 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) and interview with the Testing Personnel (TP), the laboratory failed to ensure the FR included all required information for tests performed from 11/1/16 to the date of the survey. The findings include: 1. The FR did not have the address of the laboratory where tests were performed. 2. The FR did not have the "Test Report Date". 3. The FR did not have units and interpretation for analytes on the FR. 4. The FR did not have the name of all tests performed. 5. The TP #1 listed on CMS form 209 confirmed on 11/16/18 at 2:10 pm that the laboratory did not have required information on the FR. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and 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 -- maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on lack of a Quality Assessment (QA) policy and interview with the Testing Personnel (TP), the Laboratory Director failed to ensure that a QA program was established from 11/1/16 to the date of survey. The TP #1 listed on CMS form 209 confirmed on 11/16/18 at 1:50 pm that the laboratory did not have a QA program. -- 2 of 2 --