Northwest Physicians Associates Pc

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute's (API) proficiency testing (PT) records and interview with the Laboratory Manager (LM), the laboratory failed to verify the accuracy of hematology/coagulation ungraded results for 2 of 5 API PT events for 2022 and 2023. Findings include: 1. On the day of survey, 09/14/2023 at 14: 05 PM, review of the laboratory's API PT records revealed that the laboratory did not verify the accuracy for the following hematology/coagulation API events that were not graded in 2022 and 2023: -API 1st Event 2023: Platelet Estimate (DIF). -API 2nd Event 2022: Basophil, Eosinophil, Lymphocyte, Monocyte, Neutrophil Band, Neutrophil Segmented, NRBC, Platelet Estimated. 2. The LM confirmed the findings above on 09/14/2023 at 16:15 PM 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 D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the American proficiency institute (API) proficiency testing (PT) records and interview with the technical consultant (TC) and Director of Operations, the laboratory director failed to sign the API PT attestation statements form 2019 and 2020. Findings Include: 1. On the day of survey, 08/18/2021, review of the API PT records revealed, the following event attestation statements were not signed by the laboratory director in 2019 and 2020: - 2019 API - Event #3 Chemistry. - 2019 API - Event #3 Hematology. - 2020 API - Event #1 Chemistry. 2. The TC and Director of Operations, confirmed the findings above on 08/18/2021 around 9:20 am. 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 review of the laboratory procedure manuals and interview with the technical consultant (TC) and Director of Operations, the laboratory failed to establish a competency assessment (CA) procedure to assess 1 of 1 clinical consultant (CC) and 1 of 1 TC for competency from 2019 to the day of survey. Findings include: 1. On 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 -- day of survey, 08/18/2021, the laboratory could not provide a written CA policy to assess the competency of 1 of 1 CC and 1 of 1 TC for competency in 2019, 2020 and 2021. 2. The TC and Director of Operations confirmed the findings above on 08/18 /2021 around 09:00 am. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of manual differential stain records and interview with the technical consultant (TC) and Director of Operations, the laboratory failed to test the manual differential stain (Quick III Stain) for reactivity each day of patient use for 128 out of 128 specimen examined from 08/18/2019 to 12/31/2020. Finding Include: 1. The Peripheral Blood examination Procedure states, "Quality Control: 1. Hematology stain Log must be checked daily". 2. On the day of survey, 08/18/2021, a review of the manual differential stain records revealed, the laboratory did not document stain reactivity each day of patient testing from 08/18/2019 to 12/31/2020. 3. In 2019 (08/18 /2019 to 12/31/2019), 41 manual differential specimens were examined. 4. In 2020, 87 manual differential specimens were examined. 5. The TC and the director of operations confirmed the findings above on 08/18/2021 around 10:20 am. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the CASPER Report 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analyte Free Throxine and subspecialty Endocrinology. Refer to D2107, D2108. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analyte: Free Thyroxine (F4). The laboratory had unsatisfactory scores for the 1st event of 2019 and the 3rd event of 2019. Findings include: Analyte Year Event Score F4 2019 1 20% F4 2019 3 60%. D2108 ENDOCRINOLOGY CFR(s): 493.843(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER Report 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance in the subspecialty Endocrinology. The laboratory had unsatisfactory scores for the 1st event of 2019, and the 3rd event of 2019. Findings include: Subspecialty Year Event Score Endocrinology 2019 1 73% Endocrinology 2019 3 66% -- 2 of 2 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation and interview with the Laboratory Working Manager at the time of the survey (10:30 05/09/2019), the laboratory failed to document maintenance for 2 of 2 microscopes. Findings include: 1. The Laboratory failed to document microscope maintenance after February 2017 for the (Hund Wetzlar) microscope, and the (Leica DM 750) microscope, used for reading urine sediments. 2. Observation of the Microscopes revealed, both microscopes had maintenance stickers dated (02/2017). 3. During the survey (10:30 05/09/2019), the Laboratory Working Manager confirmed the above findings. 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; 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, the review of testing personnel competency assessment records, and testing personnel interview the Laboratory Director failed to ensure competency was maintained for 1 of 2 testing personnel, who performed patient testing on the Beckman Coulter AU 480 Chemistry Analyzer. from (04/12/2019), through date of survey (05/09/2019). Findings: 1) On the date of survey (05/09/2019), the laboratory's testing personnel competency assessment records, revealed Testing Personnel 1 did not have an annual competency assessment performed within 12 months of the previous competency performed (04/12/2018), for the Beckman Coulter AU 480 Chemistry Analyzer. 2) During the survey (13:00 05/09/2019), Testing Personnel 1 confirmed the above finding. -- 2 of 2 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)