Classen Urgent Care Moore

Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/18/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant at the conclusion of the survey. 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 a review of records, observation, and interview with the technical consultant, the laboratory failed to ensure eight of eight Quantiferon (QFT) tubes had not exceeded their expiration date and and were available for use. Findings include: (1) On 12/18/2024 at 10:00 am, the techincal consultant stated that the laboratory collected blood for quantiferon testing that was sent to a reference lab for testing; (2) Observation of the laboratory on 12/18/2024 at 10:00 am identified eight QFT tubes had exceeded thier expiration dates: (a) Two yellow top QFT tubes, lot #1083244 with an expiration date of 3/31/2024; (b) Two grey top QFT tubes, lot #1083242 with an expiration date of 3/31/2024; (c) Two purple top QFT tubes, lot #1083245 with an expiration date of 04/30/2024; (d) Two green top QFT tubes, lot #1083243 with an expiration date of 3/31/2024. (3) Interview with the technical consultant on 12/18 /2024 at 10:00 am confirmed the quantiferon tubes were expired and available for use. 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 D0000 The recertification survey was performed on 02/09/2023. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the technical consultant at the conclusion of the survey. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the technical consultant failed to ensure competency evaluations had been performed semiannually during the first year of testing for one of four testing persons. Findings include: (1) On 02/09/2023 at 10:30 am, the technical consultant stated the laboratory performed CBC (Complete Blood Count) testing using the Sysmex XN-330; (2) A review of personnel records for four persons hired to perform moderate complexity testing after the previous recertification survey identified the following for one of four persons: (a) Testing Person #4 - The initial training was completed on 02/28/2022. There was no evidence a competency evaluation had been performed to date. (2) The records were reviewed with the technical consultant who stated on 02/09/2023 at 12:45 pm, a semiannual competency evaluation had not been performed as stated above. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. 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 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the technical consultant failed to ensure competency evaluations had been performed at least annually for two of three testing persons. Findings include: (1) On 02/09/2023 at 10: 30 am, the technical consultant stated the laboratory performed CBC (Complete Blood Count) testing using the Sysmex XN-330; (2) A review of personnel records for three persons performing testing during 2021, 2022, and to date in 2023 identified the following for two of three persons: (a) Testing Person #6 - Initial training had been completed on 12/19/2021. There was no documentation an annual competency evaluation had been performed (due December 2022); (b) Testing Person #7 - Initial training had been completed on 12/21/2021. There was no documentation an annual competency evaluation had been performed (due December 2022). (3) The records were reviewed with the technical consultant who stated on 02/09/2023 at 12:45 pm, annual competency evaluations had not been performed as stated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/02/2021. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant at the conclusion of the survey. 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, written policy, and interview with the technical consultant, the laboratory failed to have a written technical consultant competency policy based on the position responsibilities as listed in Subpart M. Findings include: (1) The surveyor reveiwed the competency assessment policy. It did not include guidance for assessing the competency of the technical consultant; (2) The surveyor then reviewed personnel records for competency assessments performed during 2019 and 2020. Although competencies had been performed for the technical consultant, based on their job responsibilities on 02/21/2019 and 06/01/2020, there was no policy to detail the responsibilities and define the frequency of the competencies; (3) The surveyor asked the technical consultant if a written policy to evaluate the technical consultant based on job responsibilities was available. The technical consultant stated to the surveyor on 03/02/2021 at 10:00 am, a policy had not been written. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to have a method to verify the accuracy of COVID-19 Antibody testing at least twice annually. Findings include: (1) On 03/02/2021 at 10:30 am, the technical consultant stated the following to the surveyor: (a) The laboratory began performing COVID-19 Antibody testing using the Hangzhou Biotest Biotech Rightsign test kit and plasma samples on 08/28/2020; (b) The test kit was temporarily discontinued on 10/11/2020, put back into use on 12/03/2020, and was currently being used in the laboratory. (2) The surveyor reviewed proficiency testing records for 2020 and the enrollment for 2021. The laboratory had not enrolled and participated in a proficiency testing program for COVID-19 Antibody testing for this test method; (3) Since the laboratory was not enrolled in proficiency testing (participation in a proficiency testing program is not required for COVID-19 Antibody testing; it is not a regulated test), the surveyor asked the technical consultant to explain if the laboratory had a method in place to verify the testing for accuracy and if the testing had been verified for accuracy since they began the testing. The technical consultant stated to the surveyor on 03/02/2021 at 11:45 am the laboratory did not have a method in place to verify the testing for accuracy and the testing had not been verified for accuracy to date. 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 the technical consultant, the laboratory failed to ensure an analyzer and materials were stored as required by the manufacturer for 2 of 14 months. Findings include: (1) On 03 /02/2021 at 10:00 am, the technical consultant stated the following to the surveyor: (a) CBC (Complete Blood Count) testing was performed on the Sysmex XN-330 analyzer; (b) The laboratory used three levels of Sysmex XN-L Check 10 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 in Chapter 5, Section 5.1 required a room temperature of 15-25 degrees Centigrade (C) and a humidity of 20-80%; (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 14 months (January 2020 through February 2021) and identified that temperatures and humidity had not been documented during 2 of 14 months as follows: (a) September 2020 - 2 of 30 days (i) 09/25 - The humidity, room, and refrigerator temperatures had not been documented; (ii) 09/26 - The humidity, room, and refrigerator temperatures had not been documented. (b) October 2020 - 8 of 31 days (i) 10/01 - The humidity, room, and refrigerator temperatures had not been -- 2 of 3 -- documented; (ii) 10/03 - The humidity, room, and refrigerator temperatures had not been documented; (iii) 10/14 - The humidity, room, and refrigerator temperatures had not been documented; (iv) 10/17 - The humidity and room temperature had not been documented; (v) 10/18 - The humidity and room temperature had not been documented; (vi) 10/19 - The humidity and room temperature had not been documented; (vii) 10/21 - The humidity, room, and refrigerator temperatures had not been documented; (viii) 10/27 - The humidity, room, and refrigerator temperatures had not been documented. (4) The surveyor reviewed the records with the technical consultant who stated to the surveyor on 03/02/2021 at 1:30 pm, the humidity, room temperature, and refrigerator temperatures had not been documented on the above days. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory director/designee failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H for 2 of 6 events. Findings include: (1) The surveyor reviewed 2019 and 2020 proficiency testing events, and identified for 2 of 6 events, the attestation statements had been signed approximately 1-2 months after the samples had been tested (not within a timeframe for the director/designee to attest that, at the time of testing, the proficiency samples had been tested as required) as follows: (a) Third 2019 Hematology Event - The sample testing had been completed on 11/16/2019, and the attestation statement had not been signed by the laboratory director/designee until 02/07/2020 (the graded evaluation had been received on 12/18/2020); (b) Third 2020 Hematology Event - The sample testing had been completed on 11/19/2020, and the attestation statement had not been signed by the laboratory director/designee 12/25 /2020 (the graded evaluation had been received on 12/16/2020). (2) The surveyor reviewed the findings with the technical consultant, who stated on 03/02/2021 at 11: 00 am the attestations above had been signed approximately 1-2 months after the proficiency samples had been tested. The surveyor explained that attestation statements must be signed within a timeframe to definitively attest to the fact that proficiency samples were tested in the same manner as patient specimens. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The initial certification survey was perfomed on 01/16/19. The laboratory was found out of compliance with the following CLIA regulations: 493.801: D2000: Conditon: Enrollment and Testing of Samples 493.1403: D6000: Condition: Laboratory Director, Moderate Complexity The findings were reviewed with the technical consultant at the conclusion of the survey by phone. 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 a review of manufacturer's instructions, and interview with the technical consultant and testing person #2, the laboratory failed to follow the manufacturer's instructions for waived testing. Findings include: ROOM TEMPERATURE (1) At the beginning of the survey, the technical consultant stated to the surveyor the laboratory began patient testing on 07/30/18 and performed the following waived testing: (a) Influenza A & B testing using the BD Veritor reader and test kit; (b) Chemistry testing (e.g., Albumin, Sodium, Potassium, Uric Acid, etc.) using the Piccolo Xpress Chemistry analyzer; (c) Fingerstick Glucose testing using the HemoCue 201; (d) Macroscopic urinalysis testing using the Consult 10SG urine reagent dipsticks with the dipstick reader. (2) The surveyor then reviewed laboratory temperature records but there was no documentation the laboratory temperature had been monitored from 07 /30/18 through 12/07/18. The surveyor asked the technical consultant if additional temperature records were available. Testing person #2 stated to the surveyor, the laboratory temperature had not been monitored until 12/07/18 when the temperature /humidity meter was received; (3) The surveyor then reviewed the manufacturers' temperature requirements for the testing and identified the following: (a) BD Veritor Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- reader and Influenza A & B test kit: The manufacturer required a storage and operating temperature between 15-30 degrees C (Centigrade); (b) Piccolo Xpress Chemistry analyzer: The manufacturer required a storage and operating temperature between 15-32 degrees C; (c) HemoCue 201: The manufacturer required a storage and operating temperature between 18-30 degrees C; (d) McKesson Consult Diagnostics 10SG urine reagent dipsticks: The manufacturer required a testing temperature between 15-30 degrees C. (4) The surveyor reviewed the manufacturers' temperature requirements with the technical consultant and explained the only requirement for performing waived testing is to follow the manufacturer's instructions. In order to prove the manufacturers' temperature requirement is met, the laboratory temperature must be monitored and documented on a regular (i.e. daily) basis; (5) The technical consultant stated to the surveyor the laboratory failed to ensure the manufacturers' temperature requirements for the testing listed above had been met. HUMIDITY (1) The surveyor reviewed the manufacturers' humidity requirement for the waived testing performed by the laboratory and identified the following: (a) Piccolo Xpress Chemistry analyzer: The manufacturer required a storage and operating humidity between 8-80%; (b) HemoCue 201: The manufacturer required a storage and operating humidity of less than 90%; (c) McKesson Consult Diagnostics dipstick reader: The manufacturer required a storage and operating humidity of less than 85%. (2) The surveyor reviewed the humidity records but there was no documentation the laboratory humidity had been monitored from 07/30/18 through 12/07/18. The surveyor asked the technical consultant if additional records were available. Testing person #2 stated to the surveyor, the laboratory humidity had not been monitored until 12/07/18 when the temperature/humidity meter was received; (3) The surveyor reviewed the manufacturers' requirements with the technical consultant and explained the only requirement for performing waived testing is to follow the manufacturer's instructions. In order to prove the manufacturers' humidity requirement is met, the humidity must be monitored and documented on a regular (i.e. daily) basis; (4) The technical consultant stated to the surveyor the laboratory failed to ensure the manufacturers' humidity requirements for the testing listed above had been met. 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 the technical consultant, 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, the technical consultant stated to the surveyor the laboratory began CBC (Complete Blood Count) testing (i.e., WBC-White Blood Count, RBC (Red Blood Count), Hemoglobin, Hematocrit, Platelet count, etc.) using the Sysmex XN-330 analyzer on 07/30/18; (2) The surveyor asked the technical consultant for proficiency testing records. The technical consultant stated to the surveyor the laboratory had not -- 2 of 8 -- participated in any proficiency testing events; (3) The surveyor then asked the technical consultant if the laboratory had enrolled in a proficiency testing program before performing patient testing. The technical consultant stated to the surveyor, the laboratory had not enrolled in a proficiency testing program until 11/21/18; (4) The surveyor reviewed the laboratory's proficiency testing enrollment form which stated the date ordered: 11/21/18. The surveyor explained to the technical consultant 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; (5) The technical consultant stated to the surveyor the laboratory did not enroll in proficiency testing; (6) 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 08/01/18 (b) Patient #2 - Testing performed on 08/14/18 (c) Patient #3 - Testing performed on 08/22/18 (d) Patient #4 - Testing performed on 08/24/18 (e) Patient #5 - Testing performed on 09/01/18 (f) Patient #6 - Testing performed on 09/06/18 (g) Patient #7 - Testing performed on 09 /11/18 (h) Patient #8 - Testing performed on 09/13/18 (i) Patient #9 - Testing performed on 09/24/18 (j) Patient #10 - Testing performed on 10/03/18 (k) Patient #11 - Testing performed on 10/09/18 (l) Patient #12 - Testing performed on 10/12/18 (m) Patient #13 - Testing performed on 10/28/18 (n) Patient #14 - Testing performed on 11/03/18 (o) Patient #15 - Testing performed on 11/10/18 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 policies and procedures, and interview with the technical consultant, the laboratory failed to have written policy and procedure for assessing employee competency. Findings include: (1) During the survey, the surveyor reviewed the laboratory's written policies and procedures. A policy that explained how testing persons, the technical consultant, and clinical consultant were assessed for competency could not be located; (2) The surveyor asked the technical consultant if a competency policy for assessing the competency of testing persons, the technical consultant, and the clinical consultant was available for review. The technical consultant verified a written policy and procedure had not been written. NOTE: For non-waived testing, the regulations require initial training, a semiannual evaluation during the first year, and an annual evaluation thereafter for each testing person for ensuring competency. The policy/procedure for evaluating competency must include, but is not limited to: *Direct observation of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing *Monitoring the recording and reporting of test results *Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records *Direct observation of performance of instrument maintenance and function checks *Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples *Assessment of problem solving skills NOTE: The interpretive guidelines at 493.1235, states "Competency Assessment Guidelines: Technical consultant, clinical consultant, technical supervisor, general supervisor - Documented competency assessment is required for the following named positions on the Form -- 3 of 8 -- 209: technical consultant clinical consultant, technical supervisor, general supervisor. The laboratory must have policies and procedures to assess competency based on the position responsibilities listed in Subpart M and these assessments must performed at a frequency determined by the laboratory. If these people perform testing on patient specimens, they are required to have the six required procedures in their competency assessment in addition to a competency assessment based on their federal regulatory responsibilities (see 493.1413(b)(8)/493.1451(b)(8)). 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 a review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to follow the manufacturer's instructions for quality control materials. Findings include: (1) At the beginning of the survey, the technical consultant stated to the surveyor the laboratory began patient CBC (Complete Blood Count) testing on 07/30/18 using the Sysmex XN-330 analyzer. In addition, the technical consultant stated to the surveyor the laboratory analzyed three levels (low, normal, and high) of XN-L CHECK QC (Quality Control) materials each day of patient testing; (2) The surveyor reviewed the manufacturer's instructions (package insert) for the QC materials, which stated, "When changing control lot, it is recommended to run current and new controls in parallel at least 10 times over 5 days then autoset target" (mean). The surveyor then reviewed QC records from 08/01/18 through the date of the survey and identified 9 QC lot numbers had been utilized: (a) Low, Lot #81871401; Normal, Lot #81871402; and High, Lot #81871403 - Put into use on 07/30/18 and used through 10/05/18; (b) Low, Lot #82711401; Normal, Lot #82711402; and High, Lot #82711403 - Put into use on 10/06/18 and used through 12 /20/18; (c) Low, Lot #83551401; Normal, Lot #83551402; and High, Lot #83551403 - Put into use on 12/20/18 and used through 01/16/19. (3) The records indicated for 6 of the 9 lot numbers listed above, the laboratory failed to follow the manufacturer's instructions to analyze the QC materials twice per day for 5 days: (a) Low, Lot #82711401; Normal, Lot #82711402; and High, Lot #82711403: Had been analyzed only 2 times; (b) Low, Lot #83551401; Normal, Lot #83551402; and High, Lot #83551403 - Put into use on 12/20/18: Had been analyzed only 2 times. (4) The surveyor reviewed the findings with the technical consultant who stated to the surveyor the laboratory did not follow the manufacturer's instructions for running the new QC lot numbers with the current QC lot numbers twice per day for 5 days. 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 -- 4 of 8 -- 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 the technical consultant and testing person #2, the laboratory failed to ensure the manufacturer's environmental specifications were met. Findings include: (1) At the beginning of the survey, the technical consultant stated to the surveyor the laboratory performed CBC (Complete Blood Count) testing (e.g. WBC (White Blood Count), RBC (Red Blood Count), Hematocrit, Hemoglobin, Platelet count, etc.) using the Sysmex XN-330 hematology analyzer. In addition, the technical consultant stated to the surveyor the laboratory began patient testing on 7/30/18; (2) The surveyor reviewed the manufacturer's environmental requirements. The manufacturer required a humidity between 20 and 80% and a temperature between 18-32 degrees Centigrade for optimal performance. The surveyor then reviewed the laboratory humidity /temperature records but could not find documentation which showed the humidity /temperature had been documented from 07/30/18 through 12/07/18. The surveyor asked the technical consultant if additional records were available. Testing person #2 stated the laboratory humidity/temperature had not been monitored until 12/07/18 when the humidity/temperature meter was received; (3) The surveyor reviewed the manufacturer's environmental requirements for the Sysmex XN-330 analyzer with the technical consultant. The technical consultant stated to the surveyor the laboratory failed to ensure the manufacturer's environmental specifications for the analyzer had been met during the time the humidity/temperature had not been documented. 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. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant and testing person #2, the laboratory failed to have an ongoing mechanism for performing effective analytic quality assessment. Findings include: (1) It was determined the laboratory did not have an effective mechanism for performing analytic quality assessment due to the following issues identified during the survey: (a) The laboratory failed to follow the manufacturer's instructions for quality control materials. Refer to D5411; (b) The laboratory failed to ensure the manufacturer's environmental specifications had been met. Refer to D5413. 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: -- 5 of 8 -- Based on a review of records, manufacturer's instructions, and interview with the technical consultant and testing person #2, the laboratory director failed to provide overall management and direction in accordance with 493.1407 of this subpart. Findings include: (1) The laboratory director failed to ensure test methods were performed as required by the manufacturer to ensure accurate and reliable results were reported. Refer to D6014; (2) The laboratory director failed to ensure the laboratory was enrolled in an HHS approved proficiency testing program for the testing performed in the laboratory. Refer to D6015; (3) The laboratory director failed to ensure the laboratory established and maintained an effective quality assessment program to assure the quality of laboratory services. Refer to D6021; (4) The laboratory director failed to ensure individuals performing moderate complexity testing had the appropriate training. Refer to D6029. 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 a review of records, manufacturer's instructions, and interview with the technical consultant and testing person #2, the laboratory director failed to ensure test methods were performed as required by the manufacturer to ensure accurate and reliable results were reported. Findings include: (1) The laboratory director failed to ensure the laboratory followed the manufacturer's instructions. Refer to D5411; (2) The laboratory failed to ensure the manufacturer's environmental specifications had been met. Refer to D5413. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory director failed to ensure the laboratory was enrolled in an HHS approved proficiency testing program for the testing performed in the laboratory. Findings included: (1) The laboratory director failed to ensure the laboratory enrolled in a proficiency testing program for CBC testing. Refer to D2000. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) -- 6 of 8 -- 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 a review of records, manufacturer's instructions, written policy and procedure, and interview with the technical consultant, and testing person #2, the laboratory failed to ensure an effective quality assessment program had been established and maintained to assure the quality of laboratory services. Findings include: (1) The laboratory director failed to ensure the laboratory had an effective quality assessment program due to the issues identified during the survey. Refer to D5791. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory director failed to ensure individuals performing moderate complexity testing had the appropriate training. Findings include: (1) At the beginning of the survey, the technical consultant stated to the surveyor, the laboratory began CBC (Complete Blood Count) testing on 07/30/18 using the Sysmex XN-330 analyzer; (2) The surveyor then reviewed personnel records for the 9 testing persons who performed the moderate complexity CBC testing (testing persons rotated to an associated laboratory, dependent on staffing needs.) The surveyor identified for 7 of the 9 testing persons, the initial orientation/training forms were not specific for the laboratory (i.e., Classen Care Urgent Care-Moore) and did not include training which covered the operation, maintenance, reagents, control procedures, etc., for the Sysmex XN-330 analyzer, but for the Medonic M-Series analyzer. In addition the records indicated training was performed at the sister clinic (Classen Care Urgent Care- Norman) and was conducted prior to the date the laboratory (i.e., Classen Care Urgent Care-Moore) began patient testing. The findings follow: (a) For 7 of the 9 testing persons: (i) Testing person #1: The date of the initial training was 03/08/18; (ii) Testing person #2: The Sysmex Quiz was given on 03/06/18. The date of the initial training was 06/02/18; (iii) Testing person #3: The Sysmex Quiz was given on 03/06 /18. The date of the initial training was 03/06/18; (iv) Testing person #4: The Sysmex Quiz was given on 03/06/18. The date of the initial training was 04/28/18; (v) Testing person #6: The Sysmex Quiz was given on 03/06/18. The date of the initial training -- 7 of 8 -- was 03/06/18; (vi) Testing person #7: The Sysmex Quiz was given on 03/07/18. The date of the initial training was 03/07/18; (vii) Testing person #8: The Sysmex Quiz was given on 03/06/18. The date of the initial training was 08/14/18. (b) For 1 of the 9 testing persons (Testing person #9), there was no documentation an initial training had been performed. (3) The surveyor reviewed the findings with the technical consultant who stated to the surveyor: (a) The initial training for the testing persons listed above was not specific for the testing performed at this laboratory; (b) There was no documentation to prove testing person #9 had been initially trained to perform moderate complexity testing. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant and testing person #2, the technical consultant failed to ensure the establishment and maintenance of acceptable levels of analytic performance. Findings include: (1) The technical consultant failed to ensure the laboratory followed the manufacturer's instructions. Refer to D5411; (2) The technical consultant failed to ensure the manufacturers' environmental specifications had been met. Refer to D5413. -- 8 of 8 --