Coughran Medical Group

Summary Statement of Deficiencies D0000 A Recertification survey was performed on August 23, 2022 at Coughran Medical Group, CLIA ID # 19D2045763. 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: Based on review of the laboratory's policies and procedures for waived testing and interview with personnel, the laboratory failed to have a complete policy and procedure for the reporting of SARS CoV-2 test results to the appropriate state agency. Findings: 1. Review of the laboratory's policy manual revealed the laboratory did not include the following written policy: a) Written, detailed instructions for the reporting of SARS CoV-2 test results to the state public health agency, to include but not limited to who is responsible for reporting test results and the frequency at which reporting is performed. 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. 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 -- (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 the manufacturer's operator manual, laboratory's temperature logs and interview with personnel, the laboratory failed to document the room temperature where laboratory instrumentation are maintained. Findings: 1. Observation by surveyor during the laboratory tour on August 23, 2022 revealed the laboratory utilizes the following instrumentation for patient testing: a) Sysmex XP-300 Hematology analyzer b) Beckman Coulter Access 2 Chemistry analyzer 2. Review of the manufacturer's operator manual for Hematology and Chemistry instruments maintained in the laboratory revealed the following environmental conditions: a) Sysmex XP-300: ambient temperature of 15-30 degrees celsius (59-86 degrees fahrenheit) b) Beckman Coulter Access 2: ambient temperature of 18-28 degrees celsius (64-82 degrees fahrenheit) 3. Review of the laboratory's temperature records for January 2021 through July 2022 revealed the laboratory documents the room temperature each day of patient testing with an acceptable range of 20-32 degrees celsius/68-89.6 degrees fahrenheit. 4. Further review of the laboratory's temperature records for January 2021 through July 2022 revealed the laboratory did not document the room temperature for the following two (2) of nineteen (19) months reviewed: a) November 2021 b) December 2021 5. In interview on August 23, 2022 at 10:46 am, Testing Personnel 2 stated that something spilled onto the temperature logs and the logs were not legible. Testing Personnel 2 further stated the temperature logs were rewritten using the information from the original logs and the room termperature values were not carried over to the new documentation. 6. In further interview on August 23, 2022 at 10:46 am, Technical Consultant stated that he missed the room temperature documentation upon his monthly quality assurance checks. Technical Consultant confirmed the identified room temperture records were not documented as required. 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 observation by surveyor and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5413. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on observation by surveyor, review of laboratory policy and records as well as interview with personnel, the Technical Consultant failed to provide technical and scientific oversight to the laboratory. Refer to D5413. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Certification Survey was performed on December 11, 2020 at Coughran Medical Group, CLIA ID # 19D2045763. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 record review and interview with personnel, the laboratory failed to establish a laboratory policy and procedure manual. Findings: 1. Review of the laboratory's documents and records revealed the laboratory did not have written polices and procedures that included: a) Performance specification: detailed procedures for performing accuracy, precision (day-to-day, run-to-run, and within-run variation, as well as operator variance), reportable and reference range studies, acceptability criteria for studies, and actions to take when data from the studies fail to meet acceptability criteria 2. In interview on December 11, 2020 at 11:53 am, the Technical Consultant confirmed the above policy was not included in the laboratory policy and procedure manual. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it 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 -- 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, record review and interview with personnel, the laboratory failed to have complete precision studies for the Beckman Coulter Access 2 Chemistry analyzer. Findings: 1. Observation by surveyor during the laboratory tour on December 11, 2020 at 9:45 am revealed the laboratory utilizes the Beckman Coulter Access 2 Chemistry analyzer for patient testing for the following tests: Free Triiodothyronine (FT3), Free Thyroxine (FT4), Prostate Specific Antigen (PSA), Thyroid Stimulating Hormone (TSH), Testosterone, Vitamin B12, and Vitamin D. 2. Review of the laboratory's data revealed the following studies performed on the Beckman Coulter Access 2: a) Method Comparison for accuracy b) Simple Precision c) Linearities for Reportable Range d) Reference Range 3. Futher review of the laboratory's data revealed the following data was not included: a) Complete Precision to include Day to Day and Operator Variance 4. In interview on December 11, 2020 at 12:26 pm, the Technical Consultant stated that testing personnel participated in the studies but did not document the day to day and operator variance parts performed. II. Based on observation, record review and interview with personnel, the laboratory failed to have complete precision studies for the Sysmex XP 300 Hematology analyzer. Findings: 1. Observation by surveyor during the laboratory tour on December 11, 2020 at 9:45 am revealed the laboratory utilizes the Sysmex XP 300 Hematology analyzer for Complete Blood Count (CBC) testing. 2. Review of the laboratory's data revealed the following studies performed: a) Method Comparison for accuracy b) Simple Precision c) Reportable Range d) Reference Range 3. Further review of the laboratory's data revealed the following was not included: a) Complete Precision to include Day to Day and Operator Variance 4. In interview on December 11, 2020 at 11:53 am, the Technical Consultant stated the above information was not included with the performance studies. 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, record review, and interview with personnel, the Laboratory Director failed to ensure that complete verification procedures were performed. Refer to D5421 I and II. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) -- 2 of 3 -- The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(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 record review and interview with laboratory personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel. Refer to D5401. D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Technical Consultant failed to ensure performance specification verification studies were complete. Refer to D5421 I and II. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Certification Survey was conducted on April 16, 2018 at Coughran Medical Group - CLIA ID # 19D2045763. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard 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: Based on observation and interview with personnel, the laboratory failed to ensure calibrators and blood collection tubes have not exceeded their expiration date. Findings: 1. Observation by surveyor during the laboratory tour on April 16, 2018 revealed the following expired items: a. Two (2) 2.5 ml vials Cell Dyn 18 Plus Calibrator Lot 80430 Exp 03-28-2018 b. One (1) Purple top microtainer Lot 6137925 Exp 10-2017 2. In interview on April 16, 2018, Personnel 2 and 3 confirmed the above were expired and in place for 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 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 -- 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 observation, record review, and interview with personnel, the laboratory failed to establish their own means and ranges for Quality Control (QC) material utilized for hematology testing. Findings: 1. Observation by surveyors during laboratory tour on April 16, 2018 revealed the laboratory utilizes an Abbott Cell Dyn Emerald analyzer with Cell Dyn 18 Plus quality controls for Complete Blood Count (CBC) testing. 2. Review of the manufacturer's package insert for the Cell Dyn 18 Plus controls under "Performance Characteristics" revealed "The mean assay values are derived from repetitive testing on several instruments operated and maintained according to the manufactuter's instructions; they do not necessarily apply to a single instrument. The recovery ranges are intended to reflect inter-laboratory and inter- instrument variability; thus they are wider than the +/-2 SD QC range for one instrument". 3. Review of the laboratory's QC records from April 2017 through April 2018 revealed the following Cell Dyn 18 Plus Hematology Controls utilized without establishment of means and ranges: a. Lot 8071 (L, N, H) Exp 6/29/18 - Put in use 4 /11/18 b. Lot 7268 (L, N, H) Exp 1/12/18 - Put in use 9/27/17 c. Lot 7156 (L, N, H) Exp 9/22/17 - Put in use 7/25/17 d. Lot 7100 (L, N, H) Exp 7/28/17 - Put in use 4/12 /17 3. In interview on April 16, 2018 at 2:32 pm, Personnel 2 stated the laboratory utilizes the manufacturer's means and ranges and that he was unaware that QC needed to be established. 4. Review of the Task 1 & 3 form provided to surveyors by personnel revealed the laboratory performs one thousand six hundred (1600) CBCs annually. 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 observation, record review, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel were performing test methods as required for accurate and reliable results. Refer to D5417. D6020 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 -- 2 of 3 -- director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure that the quality control was maintained to assure quality laboratory services were provided. Refer to D5469. -- 3 of 3 --