Ssm Health Medical Group Family Medicine Choctaw

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/19/2021. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with testing person #1 at the conclusion of the survey. 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 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 a review of records and interview with testing person #1, the laboratory failed to ensure an attestation statement had been signed by the laboratory director or designee for 3 of 5 events. Findings include: (1) The surveyor reviewed 2019 (third event), 2020 (first, second, and third events) and 2021 (first event) Hematology proficiency testing records with the following identified: (a) First 2020 Event - The attestation statement had not been signed by the laboratory director or designee; (b) Second 2020 Event - The attestation statement had not been signed by the laboratory director or designee; (c) First 2021 Event - The attestation statement had not been 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 -- signed by the laboratory director or designee. (2) The surveyor reviewed the records with testing person #1, who stated on 07/19/2021 at 10:30 am, the attestation statements had not been signed by the laboratory director or designee. 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. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1, the laboratory failed to have a written technical consultant competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) The surveyor reviewed personnel records for competency assessments performed during 2019, 2020, and to date in 2021. There was no evidence competencies had been performed for technical consultant #2 based on job responsibilities; (2) The surveyor asked testing person #1 if a written policy to evaluate the technical consultant, based on job responsibilities, was available and if competencies had been performed during the review period. Testing person #1 stated to the surveyor on 07/19/2021 at 10:40 am, a policy to evaluate the technical consultant based on job responsibilities had not been written; and competencies had not been 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. (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 a review of records, manufacturer's instructions, and interview with testing person #1, the laboratory failed to ensure an analyzer and materials were stored as required by the manufacturer for 7 of 13 months. Findings include: (1) On 07/19/2021 at 09:30 am, testing person #1 stated the following to the surveyor: (a) CBC (Complete Blood Count) testing was performed on the Cell Dyn Emerald analyzer; (b) The laboratory used three levels of Cell Dyn 18 Plus quality control (QC) materials to perform QC each day of patient testing. (2) The surveyor reviewed the manufacturer's environmental requirements for the analyzer and the storage requirements for the QC material: (a) The operator's manual for the analyzer on page 2-4 under "Installation Environment" required a room temperature of 18-32 degrees Centigrade (C) and 64- 90 degrees (F) Fahrenheit; (b) The package insert for the QC materials required storage at 2-8 degrees C. (3) The surveyor reviewed laboratory temperature and humidity records for 13 months (July 2020 through June 2021) and identified that temperatures had not been documented during 7 of 13 months as follows: (a) July 2020 - 4 of 21 days (i) 07/08 - The room and refrigerator temperatures had not been -- 2 of 3 -- documented; (ii) 07/16 - The room temperature had not been documented; (iii) 07/17 - The refrigerator temperature had not been documented; (iv) 07/22 - The room and refrigerator temperatures had not been documented. (b) August 2020 - 1 of 23 days (i) 08/05 - The refrigerator temperature had not been documented. (c) September 2020 - 1 of 22 days (i) 09/17 - The room temperature had not been documented. (d) October 2020 - 2 of 22 days (i) 10/22 - The room temperature had not been documented; (ii) 10 /27 - The room temperature had not been documented. (e) November 2020 - 1 of 22 days (i) 11/24 - The room temperature had not been documented. (f) January 2021 - 5 of 20 days (i) 01/05 - The room temperature had not been documented; (ii) 01/11 - The room temperature had not been documented; (iii) 01/18 - The room temperature had not been documented; (iv) 01/19 - The room temperature had not been documented; (v) 01/20 - The room and refrigerator temperatures had not been documented. (g) February 2021 - 3 of 19 days (i) 02/10 - The room temperature had not been documented; (ii) 02/13 - The room temperature had not been documented; (iii) 02/17 - The room temperature had not been documented. (h) March 2021 - 1 of 23 days (i) 03/10 - The room temperature had not been documented. (i) April 2021 - 2 of 22 days (i) 04/28 - The room temperature had not been documented; (ii) 04/29 - The room temperature had not been documented. (j) May 2021 - 1 of 23 days (i) 05 /14 - The refrigerator temperature had not been documented. (4) The surveyor reviewed the records with testing person #1 who stated to the surveyor on 07/19/2021 at 12:30 pm, the room and refrigerator temperatures had not been documented on the above days. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/06/19. The laboratory was found out of compliance with the following CLIA regulations with standard deficiencies cited: 493.801: D2000: Condition: Enrollment and Testing of Samples 493.1403: D6000: Condition: Laboratory Director, Moderate Complexity The findings were reviewed with testing person #1, technical consultant, office manager, and the office administrator at the conclusion of the survey. 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 a review of records and interview with testing person #1, the laboratory failed to enroll in an HHS approved proficiency testing program for the testing performed by the laboratory. Findings include: (1) At the beginning of the survey, testing person #1 stated to the surveyor the laboratory performed CBC (Complete Blood Count) testing (i.e., WBC-White Blood Count, RBC (Red Blood Count), Hemoglobin, Hematocrit, Platelet count, etc.) using the Cell Dyn Emerald hematology analyzer; (2) The surveyor asked testing person #1 for proficiency testing records from 2018 through the present. Testing person #1 stated to the surveyor, the laboratory had not enrolled in proficiency testing for the First and Second events of 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 -- 2018 but had enrolled in the program in time to participate in the Third event of 2018 and enrolled in proficiency testing for 2019; (3) The surveyor reviewed the laboratory's proficiency testing enrollment form which stated the laboratory enrolled in proficiency testing for 2018 on 11/12/18. The surveyor explained to testing person #1 laboratories are required by CMS to enroll in an HHS approved proficiency testing program for each of the specialties and subspecialties for which it seeks certification; (4) Examples of patients with CBC testing performed when the laboratory failed to enroll and participate in proficiency testing included the following: (a) Patient #1 - Testing performed on 01/11/18 (b) Patient #2 - Testing performed on 02/01/18 (c) Patient #3 - Testing performed on 03/14/18 (d) Patient #4 - Testing performed on 04 /13/18 (e) Patient #5 - Testing performed on 05/04/18 (f) Patient #6 - Testing performed on 06/22/18 (g) Patient #7 - Testing performed on 07/16/18 (h) Patient #8 - Testing performed on 08/03/18 (i) Patient #9 - Testing performed on 09/17/18 (j) Patient #10 - Testing performed on 10/11/18 (k) Patient #11 - Testing performed on 11 /01/18 D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1 and the technical consultant, the laboratory failed to verify the accuracy of proficiency testing results which had not been evaluated by the proficiency testing program. Findings include: (1) At the beginning of the survey, testing person #1 stated to the surveyor the laboratory used the Cell Dyn Emerald hematology analyzer to perform CBC (Complete Blood Count) testing that included a total Platelet Count; (2) The surveyor reviewed proficiency testing records from 08/25/17 through 06/06/19 and identified the proficiency testing program had not evaluated the laboratory's Platelet Count response for 1 of the 5 samples in the First Hematology event of 2019: (a) Sample Hem-02: (i) The laboratory reported, "39"; (ii) The proficiency testing programs expected response was, "49-83"; (iii) In addition, the proficiency testing program had not graded the laboratory's response due to "No Consensus" among the participants. (3) The surveyor then reviewed the proficiency testing program's "Performance Review and