Family Doctors

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted December 18, 2024 at The Family Doctors - CLIA ID # 19D0463919. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. 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 observation by surveyor, review of laboratory policy, manufacturer instructions and laboratory freezer temperatures, as well as interview with personnel, the laboratory failed to define acceptable freezer temperature limits within the manufacturer's acceptable ranges. Findings: 1. Observation by surveyor during the laboratory tour on December 18, 2024 at 2:47 pm revealed the laboratory stores the following supplies in the freezer: a) BioRad Liquid Unassayed Multiqual Control (1) - Lot 56741 Expiration 8/31/26 b) BioRad Liquid Unassayed Multiqual Control (3) - Lot 56743 Expiration 8/31/26 c) BioRad Liquichek Immunoassay Plus Control (1) - Lot 85371 Expiration 8/31/26 d) BioRad Liquichek Immunoassay Plus Control (3) - Lot 85373 Expiration 8/31/26 e) BioRad Liquichek Specialty Immunoassay Control (2) - Lot 65002 Expiration 9/30/26 2. Review of the laboratory policy "Temperature Checks" under "Temperature Ranges" revealed the following: "Freezers; temperatures shall be maintained at -20 degrees celsius or below for storage of research specimens, reference lab specimens, QC material and controls". 3. Review of the manufacturer's 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 -- instruction for the BioRad quality controls revealed the following acceptable ranges: a) BioRad BioRad Liquid Unassayed Multiqual Control (1) - acceptable ranges -20 degrees celsius to -70 degrees celsius b) BioRad Liquid Unassayed Multiqual Control (3) - acceptable ranges -20 degrees celsius to -70 degrees celsius c) BioRad Liquichek Immunoassay Plus Control (1) - acceptable ranges -20 degrees celsius to -70 degrees celsius d) BioRad Liquichek Immunoassay Plus Control (3) - acceptable ranges -20 degrees celsius to -70 degrees celsius e) BioRad Liquichek Specialty Immunoassay Control (2) - acceptable ranges -20 degrees celsius to -70 degrees celsius 4. Review of the laboratory freezer temperature logs from January 2024 through October 2024 revealed the following ninety five (95) of two hundred seven (207) days in 2024 had unacceptable temperatures documented: a) January 3, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) b) January 5, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) c) January 9, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) d) January 12, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) e) January 18, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) f) January 29, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) g) January 30, 2024 - temperature documented as -17 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) h) February 6, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) i) February 8, 2024 - temperature documented as -16 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) j) February 12, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) k) February 13, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) l) February 16, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) m) February 21, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) n) February 26, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) o) February 27, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) p) March 1, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) q) March 25, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) r) April 3, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) s) April 4, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) t) April 5, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) u) April 8, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) v) April 11, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) w) April 12, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) x) April 15, 2024 - temperature documented as -15 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) y) April 16, 2024 - temperature documented as -17 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) z) April 17, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) aa) April 22, 2024 - temperature documented as -17 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) bb) April 23, 2024 - temperature -- 2 of 6 -- documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) cc) April 24, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) dd) April 25, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) ee) May 6, 2024 - temperature documented as -17 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) ff) May 8, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) gg) May 21, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) hh) May 24, 2024 - temperature documented as -16 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) ii) June 12, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) jj) June 20, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) kk) June 26, 2024 - temperature documented as -17 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) ll) June 27, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) mm) July 1, 2024 - temperature documented as -16 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) nn) July 5, 2024 - temperature documented as -16 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) oo) July 8, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) pp) July 9, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) qq) July 10, 2024 - temperature documented as -17 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) rr) July 11, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) ss) July 12, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) tt) July 15, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) uu) July 16, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) vv) July 18, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) ww) July 19, 2024 - temperature documented as -17 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) xx) July 24, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) yy) July 25, 2024 - temperature documented as -15 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) zz) July 26, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) aaa) July 30, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) bbb) July 31, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) ccc) August 1, 2024 - temperature documented as -17 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) ddd) August 2, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) eee) August 5, 2024 - temperature documented as -15 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) fff) August 6, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) ggg) August 7, 2024 - temperature documented as -16 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) hhh) August 8, 2024 - temperature documented as -17 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) iii) August 9, 2024 - temperature documented as -17 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) jjj) August 12, 2024 - temperature documented as -18 degrees celsius (acceptable -- 3 of 6 -- range of -20 degree celsius to -70 degree celsius) kkk) August 13, 2024 - temperature documented as -17 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) lll) August 14, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) mmm) August 15, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) nnn) August 16, 2024 - temperature documented as -17 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) ooo) August 19, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) ppp) August 20, 2024 - temperature documented as -16 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) qqq) August 21, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) rrr) August 23, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) sss) August 26, 2024 - temperature documented as -17 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) ttt) August 28, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree celsius to -70 degree celsius) uuu) September 3, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree to -70 degree celsius) vvv) September 5, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree to -70 degree celsius) www) September 6, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree to -70 degree celsius) xxx) September 9, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree to -70 degree celsius) yyy) September 10, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree to -70 degree celsius) zzz) September 11, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree to -70 degree celsius) aaaa) September 12, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree to -70 degree celsius) bbbb) September 13, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree to -70 degree celsius) cccc) September 16, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree to -70 degree celsius) dddd) September 17, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree to -70 degree celsius) eeee) September 18, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree to -70 degree celsius) ffff) September 19, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree to -70 degree celsius) gggg) September 20, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree to -70 degree celsius) hhhh) September 23, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree to -70 degree celsius) iiii) September 25, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree to -70 degree celsius) jjjj) September 26, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree to -70 degree celsius) kkkk) September 27, 2024 - temperature documented as -15 degrees celsius (acceptable range of -20 degree to -70 degree celsius) llll) September 30, 2024 - temperature documented as -19 degrees celsius (acceptable range of -20 degree to -70 degree celsius) mmmm) October 1, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree to -70 degree celsius) nnnn) October 2, 2024 - temperature documented as -18 degrees celsius (acceptable range of -20 degree to -70 degree celsius) oooo) October 3, 2024 - temperature documented as -17 degrees celsius (acceptable range of -20 degree to -70 degree celsius) pppp) October 9, 2024 - temperature documented as -16 degrees celsius (acceptable range of -20 degree to -70 degree celsius) 5. In interview on December 18, 2024 at 2:51 pm, the Technical Consultant confirmed the laboratory's freezer acceptable temperature range did not follow the manufacturer's -- 4 of 6 -- recommendations. D5781

Summary Statement of Deficiencies D0000 A Recertification survey was performed at The Family Doctors, CLIA ID # 19D0463919, on February 28, 2023. The Family Doctors was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic systems 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing, Laboratory Director D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing results and interview with personnel, the laboratory failed to successfully verifiy the accuracy of 25-OH Vitamin D for two (2) of four (4) consecutive proficiency testing events. Findings: 1. Review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) results from 2022 and 2023 revealed the laboratory received the following scores in two (2) of four (4) events reviewed: a) 2022 Chemistry Core 3rd event: score of 50% b) 2023 Chemistry Core 1st event: score of 0% 2. In interview on February 28, 2023 at 9:59 am, Technical Consultant 2 stated the laboratory received the scores for Vitamin D and opted to cease testing pending two (2) consecutive passing events. Technical Consultant confirmed the identified scores for proficiency testing results. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that 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 -- provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation by surveyor, review of laboratory policies and records as well as interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to establish a complete policy and procedure manual. Refer to D5401 I. 2. The laboratory failed to follow their established policy to perform water cultures monthly for six (6) of twelve (12) months reviewed in 2022. Refer to D5401 II. 3. The laboratory failed to ensure complete verification of performance studies for the Siemens Dimension EXL 200 chemistry analyzer. Refer to D5421 I. 4. The laboratory failed to ensure complete verification of performance studies for the Sysmex XN-530 Hematology analyzer. Refer to D5421 II. 5. The laboratory failed to establish procedures to monitor, assess, and correct problems, identified with the analytic system. Refer to D5791. 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: I. Based on review of the laboratory's policies and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policies revealed the laboratory did not have written policies and procedures that included the following: a) Performance specification: detailed procedures for performing accuracy and precision (day-to-day, run-to-run, and within-run, as well as, operator variance), reportable and reference range studies, and actions to take when data from the studies fail to meet acceptability criteria 2. In interview on February 28, 2023 at 10:02 am, Technical Consultant 2 confirmed the laboratory did not include the above identified policy. II. Based on review of laboratory policy and records as well as interview with personnel, the laboratory failed to follow their established policy to perform water cultures monthly for six (6) of twelve (12) months reviewed in 2022. Findings: 1. Review of the laboratory policy "Monthly Millipore Sample Collection fo Contamination" revealed "Monthly a water sample must be submitted to the reference laboratory to make sure the water system does not contain bacterial contamination". 2. Review of laboratory records for water purification revealed the laboratory did not perform a monthly water culture for the following six (6) of twelve (12) months reviewed in 2022: a) February 2022 b) April 2022 c) May 2022 d) June 2022 e) July 2022 f) September 2022 3. In interview on February 28, 2023 at 12:50 pm, Technical Consultant 2 confirmed the laboratory did not perform monthly water cultures as required by laboratory policy. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system -- 2 of 6 -- 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: I. Based on observation by surveyor, review of laboratory policy and performance specification studies as well as interview with personnel, the laboratory failed to ensure complete verification of performance studies for the Siemens Dimension EXL 200 chemistry analyzer. Findings: 1. Direct observation by surveyor during the laboratory tour on February 28, 2023 at 9:15 am revealed the laboratory utilizes the Siemens Dimension EXL 200 analyzer for the following chemistry tests: Glucose, Blood Urea Nitrogen, Creatinine, Calcium, Sodium, Potassium, Chloride, Alkaline Phosphatase, Alanine Transaminase, Aspartate Aminotransferase, Total Bilirubin, Total Protein, Albumin, Carbon Dioxide, Thyroid Stimulating Hormone, Free Thyroxine, Total Thyroxine, Microalbumin, Prostate Specific Antigen, Creatine Kinase, Hemoglobin A1C 2. Review of the laboratory's policy manual revealed the laboratory did not have a policy for performance specification studies. 3. Review of the laboratory's performance studies for the Siemens Dimension EXL 200 analyzer revealed the laboratory did not have documentation for the following: a) Complete precision to include Day to Day and Operator Variance with raw data to support studies b) Reportable Range to include raw data to support c) Reference Range to include pertinent information to support d) Acceptability criteria e) Laboratory Director approval 4. In interview on February 28, 2023 at 10:02 am, Technical Consultant 2 confirmed the laboratory did not have complete performance studies for the Siemens Dimension chemistry analyzer. II. Based on observation by surveyor, review of laboratory policy and performance specification studies as well as interview with personnel, the laboratory failed to ensure complete verification of performance studies for the Sysmex XN-530 Hematology analyzer. Findings: 1. Direct observation by surveyor during the laboratory tour on February 28, 2023 at 9:15 am revealed the laboratory utilizes the Sysmex XN-530 analyzer for Complete Blood Count (CBC) testing. 2. Review of the laboratory's policy manual revealed the laboratory did not have a policy for performance specification studies. 3. Review of the laboratory's performance studies for the Sysmex XN-530 analyzer revealed the laboratory did not have documentation for the following: a) Complete precision to include run to run, day to day, within run, and operator variance along with the raw data to support studies b) Reportable Range to include the raw data to support studies c) Reference Range to include pertinent information d) acceptability criteria e) Laboratory Director approval 4. In interview on February 28, 2023 at 10:02 am, Technical Consultant 2 confirmed the laboratory did not have complete performance studies for the Sysmex XN-530 hematology analyzer. 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. -- 3 of 6 -- This STANDARD is not met as evidenced by: Based on review of laboratory policy and records and interview with personnel, the laboratory failed to establish procedures to monitor, assess, and correct problems, identified with the analytic system. Findings: 1. Review of the laboratory policy and procedures revealed the laboratory has a quality assessment process in place; however, the following deficient practices were not identified: a) The laboratory failed to establish a complete policy and procedure manual. Refer to D5401 I. b) The laboratory failed to follow their established policy to perform water cultures monthly for six (6) of twelve (12) months reviewed in 2022. Refer to D5401 II. c) The laboratory failed to ensure complete verification of performance studies for the Siemens Dimension EXL 200 chemistry analyzer. Refer to D5421 I. d) The laboratory failed to ensure complete verification of performance studies for the Sysmex XN-530 Hematology analyzer. Refer to D5421 II. 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 observation by surveyor, review of laboratory policies and records as well as interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. Findings: 1. The Laboratory Director failed to ensure performance verification studies were complete. Refer to D6013. 2. The Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D6014. 3. The Laboratory Director failed to ensure that a complete quality assessment (QA) program was established to assure the quality of laboratory services provided. Refer to D6021. 4. The Laboratory Director failed to ensure policies and procedures for assessing personnel competency were maintained. Refer to D6030. 5. The Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Refer to D6031. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on observation by surveyor, review of laboratory policy, performance studies, and interview with personnel, the Laboratory Director failed to ensure performance verification studies were complete. Findings: 1. The laboratory failed to ensure complete verification of performance studies for the Siemens Dimension EXL 200 -- 4 of 6 -- chemistry analyzer. Refer to D5421 I. 2. The laboratory failed to ensure complete verification of performance studies for the Sysmex XN-530 Hematology analyzer. Refer to D5421 II. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review of laboratory policy and records along with interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to successfully verifiy the accuracy of 25-OH Vitamin D for two (2) of four (4) consecutive proficiency testing events. Refer to D5217. 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 maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on observation by surveyors, review of laboratory records, and interview with personnel, the Laboratory Director failed to ensure that a complete quality assessment (QA) program was established to assure the quality of laboratory services provided. Refer to D5791. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; -- 5 of 6 -- This STANDARD is not met as evidenced by: Based on review of personnel records and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were maintained. Findings: 1. The Technical Consultant failed to evaluate and complete the competency assessments of four (4) of six (6) testing personnel in 2022. Refer to D6046. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on review of laboratory policies and interview with laboratory personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Findings: 1. The laboratory failed to establish a complete policy and procedure manual. Refer D5401 I. 2. The laboratory failed to follow their established policy to perform water cultures monthly for six (6) of twelve (12) months reviewed in 2022. Refer to D5401 II. 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 review of the CMS 209 (Laboratory Personnel Report), personnel records, and interview with personnel, the Technical Consultant failed to evaluate and complete the competency assessments of four (4) of six (6) testing personnel in 2022. Findings: 1. Review of the CMS 209 form provided to surveyor revealed the the following personnel serve as Technical Consultant: a) Personnel 1 (who also serves as Laboratory Director) b) Personnel 3 2. Review of the laboratory's personnel records revealed the following four (4) of six (6) testing personnel did not have documentation of competency assessments performed in 2022: a) Personnel 4 b) Personnel 5 c) Personnel 6 d) Personnel 8 3. In interview on February 28, 2023 at 10: 31 am, Technical Consultant 2 stated that she accepted the position of technical consultant in December 2022 and was not employed during 2022. Technical Consultant 2 confirmed the competency assessments were not completed for the identified testing personnel. -- 6 of 6 --

Summary Statement of Deficiencies D0000 A Recertification Survey was performed on July 21, 2021 at Family Doctors, CLIA ID # 19D0463919. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: I. Based on observation by surveyor, review of manufacturer's instructions and test menu, as well as interview with personnel, the laboratory failed to include "Fact Sheets" to providers or patients for Emergency Use Authorization (EUA) SARS COV- 2 testing. Findings: 1. Observation during the laboratory tour on July 21, 2021 at 10: 08 am revealed the laboratory performs SARS COV-2 testing utilizing the Cepheid Gene Xpert analyzer along with the Xpert Xpress SARS-CoV-2/Flu/RSV test kit. 2. Review of the manufacturer's instructions for use under "Conditions of Authorization for Laboratory and Patient Care Settings" section revealed " Authorized laboratories using your product will include with result reports of the Xpert Xpress SARS-CoV-2 /Flu/RSV test, all authorized Fact Sheet. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media". 3. In interview on July 21, 2021 at 12:40 pm, Personnel 2 confirmed the laboratory was not aware of and does not provide the "Fact Sheets" for the COVID test to providers or patients. II. Based on observation by surveyor, review of manufacturer's quality control package inserts and laboratory quality control records as well as interview with personnel, the laboratory failed to establish its own expected range of responses for Zeptometrix Natrol quality control (QC) material. Findings: 1. Observation by surveyor during laboratory tour on July 21, 2021 at 10:08 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 -- am revealed the laboratory utilizes the Cepheid GeneXpert Xpress analyzer with Zeptometrix Natrol External Run Control for the following tests: a) SARS-CoV-2/Flu /RSV 2. Review of the ZeptoMetrix Corporation NATtrol External Run Controls package insert under "Expected Results" revealed "Each laboratory must evaluate the product and establish their own acceptance criteria". 3. Review of the laboratory's quality control (QC) records revealed the laboratory did not establish its own acceptance criteria for the ZeptoMetrix external control material. 4. In interview on July 21, 2021 at 12:40 pm, Personnel 2 stated she was unaware the Zeptometrix External QC should be established. Personnel 2 confirmed the laboratory uses the responses provided by the manufacturer and does not establish their own. D2105 ENDOCRINOLOGY CFR(s): 493.843(e) (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 the laboratory's proficiency testing records and interview with personnel, the laboratory failed to document remedial action for unacceptable Thyroxine proficiency testing scores. Findings: 1. Review of the laboratory's 2020 American Proficiency Institute (API) Proficiency Testing (PT) records revealed the laboratory received the following unacceptable results: a) 2020 Chemistry - Core - 1st event: CH-02, Thyroxine, unacceptable 2. Further review of the 2020 API Proficiency Testing records revealed the laboratory did not have documentation of

Summary Statement of Deficiencies D0000 A CERTIFICATION SURVEY was performed at The Family Doctors - CLIA # 19D0463919 on November 19, 2018. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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: **REPEAT DEFICIENCY** Based on observation and interview with personnel, the laboratory failed to ensure supplies have not exceeded their expiration date. Findings: 1. Observation by surveyor during laboratory tour on November 19, 2018 revealed the following expired items in the Phlebotomy Room: * Phlebotomy area - cabinet on 2nd shelf a) Griener Bio-one Vacuette 3mL Lithium Heparin Sep Lot B170836Q, Exp 10 /24/18, Quantity 1 tube b) BD Vacutainer 6mL Trace Element Serum (Blue) Lot 6343851, Exp 12/31/17, Quantity 3 tubes c) BD Vacutainer Trace Element K2 EDTA (Purple) Lot 616925, Exp 6/17, Quantity 2 tubes * Phlebotomy Area - cabinet below centrifuges a) Fisher Finest Bacteriology Culture Collection and Transport System (Fisher Healthcare) Lot 6F02A, Exp 12/2/17, Quantity 1 bag (50 swabs) b) Therno Scientific Versa TREK REDOX 2 8mL anaerobic Blood Culture bottles Lot 226502, Exp 10/18, Quantity 2 bottles * Phlebotomy Area - Draw station a) BD Vacutainer K2 EDTA 2mL (purple) Lot 7097854, Exp 7/31/18, Quantity 6 tubes 2. In interview on November 19, 2018 at 2:42 pm, Personnel 2 stated she was unaware that tubes were expired in the phlebotomy rack in place for patient collection. Personnel 2 further stated that the tubes were used only for short draw samples and they are rarely used except for Hemoglobin A1C testing. 3. In further interview on November 19, 2018 at 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 -- 2:50 pm, Personnel 2 stated she was unaware that some of the supplies were expired in the Phlebotomy area. Personnel 2 confirmed the above items were expired. D5781