Urgent Care - Lakewood

Summary Statement of Deficiencies 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 record review and an interview with the laboratory manager, the laboratory director and testing personnel failed to sign the attestation statements from the American Proficiency Institute (API) for all events in 2021, 2022, and event 1 in 2023. Findings include: 1. A review of the laboratory records from API, revealed the attestation statements for complete blood count samples from API were not signed by the laboratory director and testing personnel. 2. An interview on 7/18/2023, with the laboratory manager at approximately 10:00 AM, confirmed the laboratory director and testing personnel failed to sign the attestation statements for complete blood counts tests from API. 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 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 -- 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 routine proficiency test desk review of the CASPER CMS-155 report for proficiency testing performance and an interview with the laboratory manager, the laboratory failed to achieve satisfactory performance scores for Hematology overall, Red Blood Cells (RBC), Hematocrit (HCT), and Platelets (PLT) for two out of three events, event 2 in 2022, event 1 in 2023 (See D2130, D2131). The laboratory performed approximatley 400 hematology tests per year. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 proficiency testing scores from the American Proficiency Institute (API), CASPER CMS-155 report and an interview with the laboratory manager, the laboratory failed to achieve a satisfactory score of at least 80 percent for Red Blood Cells (RBC), Hematocrit (HCT), and Platelets (PLT) for two out of three events, event 2 in 2022, event 1 in 2023 for testing performed on Medonics M hematology analyzer resulting in unsuccessful performance. The laboratory performed approximatley 400 hematology tests per year. Findings include: 1. A review of the proficiency testing scores from API and the CASPER CMS-155 Individual Laboratory Profile, revealed the laboratory failed to achieve satisfactory performance for RBC, HCT, PLT. Analyte Score Event, Year RBC 0 2, 2022 RBC 20 1, 2023 HCT 0 2, 2022 HCT 40 1, 2023 PLT 0 2, 2022 PLT 60 1, 2023 2. An interview with the laboratory manager on 7/18/2023 at approximately 11:45 AM, confirmed two out of three unsuccessful proficiency test scores for RBC, HCT, PLT. D2131 HEMATOLOGY CFR(s): 493.851(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. -- 2 of 6 -- This STANDARD is not met as evidenced by: Based on a review of proficiency testing scores from the American Proficiency Institute (API), CASPER CMS-155 report and an interview with the laboratory manager, the laboratory failed to achieve a satisfactory score for Hematology overall for two out of three events, event 2 in 2022, event 1 in 2023 for testing performed on Medonics M hematology analyzer resulting in an overall unsuccessful performance. The laboratory performed approximatley 400 hematology tests per year. Findings include: 1. A review of the proficiency testing scores from API and the CASPER CMS-155 Individual Laboratory Profile, revealed the laboratory failed to achieve satisfactory performance for Hematology overall for event 2, 2022 was zero percent (0%), event 1, 2023 was sixty six percent (66%). 2. An interview with the laboratory manager on 7/18/2023 at approximately 11:45 AM, confirmed two out of three unsuccessful proficiency test scores for Hematology overall. 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 a record review and an interview with the laboratory manager, the laboratory director failed to ensure that a procedure manual was made available and followed by testing personnel who performed complete blood count tests on the Medonic M hematology analzyer since the last survey on 10/30/2020. Findings include: 1. A review of the laboratory procedure manual revealed the laboratory failed to ensure procedures were established for the Medonic M hematology analzyer and followed by 6 out of 6 testing personnel. 2. A review of the laboratory procedure manual revealed the laboratory manual contained a procedure for complete blood counts from another facility dated 2014. The original effective date of the laboratory was in 2016. 3. An interview on 7/18/2023, with the laboratory manager at approximately 2:15 PM, confirmed the laboratory director failed to ensure that a procedure manual is available for testing personnel who performed tests on the Medonic M. 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 record review, an observation, and an interview with the laboratory manager, the laboratory testing personnel #1 (TP1) failed to follow the manufacturer's instructions for performing testing on the Medonic M hematology analyzer. Findings include: 1. A review of the laboratory documents revealed the laboratory failed to -- 3 of 6 -- have the Medonic manufacturer's manual and failed to have a procedure for the test performance for complete blood counts (CBCs). 2. An observation on 7/18/2023, at approximately 12:10 PM, revealed that TP1 failed to perform the background checks and external quality control as instructed by the manufacturer. 3. The laboratory performed approximately 44 patient samples from October 2022 through July 2023. 4. An interview on 7/18/2023, with the laboratory manager at approximately 2:15 PM, confirmed the laboratory TP1 failed to follow instructions on how to perform background checks and external quality controls. 5. An interview on 7/18/2023, with TP1, at approximately 12:15 PM, revealed the TP1 was shown how to perform tests on the Medonic by another employee. D5781

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 routine desk review of the CMS-155 report for Proficiency Testing (PT) performance and email communications with the laboratory director of operations, the laboratory failed to achieve satisfactory performance scores for the American Proficiency Institute (API) PT for Cell I.D or WBC Diff testing using the Medonic M- Series instrument for three out of four PT events in 2021 and 2022 (events 3 of 2021 and events 1 and 2 of 2022). See D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a routine desk review of the CMS-155 report for Proficiency Testing (PT) performance and email communications with the laboratory director of operations, the laboratory failed to achieve a score of at least 80% for the American Proficiency Institute (API) PT for Cell I.D. or WBC Diff testing using the Medonic M-Series instrument for events 3 of 2021 and events 1 and 2 of 2022. Findings: 1. A review of the CMS-155 Individual Laboratory Profile on 10/11/2022, at 12:45 pm, revealed the API PT for Cell I.D. or WBC Diff testing scores for 2021 event 3 was 67%, for 2022 event 1 was 73% and event 2 was 0%. 2. Email received from the laboratory director of operations on 10/13/2022, at 11:32 am, confirmed three consecutive unsuccessful PT scores for Cell I.D. or WBC Diff testing due to instrument errors and failure to submit PT results before the deadline. 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 a routine desk review of the CMS-155 report for Proficiency Testing (PT) performance and email communications with the laboratory director of operations, the laboratory director failed to provide overall management of the laboratory by failing to ensure accurate instrument operation and timely submission of proficiency testing results for Cell I.D. or WBC Diff. See D6016. 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 routine desk review of the CMS-155 report for Proficiency Testing (PT) performance and email communications with the laboratory director of operations, the laboratory director failed to provide overall management of the laboratory by failing to ensure accurate instrument operation and timely submission of proficiency testing results for Cell I.D. or WBC Diff. Findings: 1. A review of the CMS-155 Individual Laboratory Profile on 10/11/2022, at 12:45 pm, revealed the API PT for Cell I.D. or WBC Diff testing scores for 2021 event 3 was 67%, for 2022 event 1 was 73% and event 2 was 0%. 2. Email received from the laboratory director of operations on 10/13 -- 2 of 3 -- /2022, at 11:32 am, confirmed three consecutive unsuccessful PT scores for Cell I.D. or WBC Diff testing due to instrument operation errors and failure to submit PT results before the deadline. -- 3 of 3 --

Summary Statement of Deficiencies 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 the quality assessment (QA) plan, personnel competency assessment records, and staff interview, the laboratory failed to follow their written policy in 2017 to assess the competency of all testing personnel who perform complete blood count (CBC) testing using the Medonic M Series hematology analyzer and approximately 1135 patients are tested annually. Findings include: a. The QA plan states that competency will be performed twice in the first year of employment and annually thereafter and will be documented. b. No competency assessment records existed to show 5 of 10 testing personnel (#3, 5, 9, 10 and 11) were evaluated for competency in 2017. c. Staff confirmed during the onsite survey on 6/21/18 at around 10:30 am, the laboratory failed to follow their QA plan and did not evaluate testing personnel for competency in 2017. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the laboratory's written policies, proficiency testing (PT) records, and staff interview, the laboratory failed to review and evaluate unsatisfactory PT results received in 2017. Findings include: a. The laboratory'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 2 -- policy for proficiency testing states, "Any unsatisfactory results will be investigated and documented by the QA Manager and verified by the Lab Director. All records will be kept in the Proficiency Testing Manual." b. Records showed an unsatisfactory PT score of 40% was received for the 2nd event of 2017 for hematocrit (HCT) in the specialty of Hematology. c. No investigation was documented to identify the root cause of this PT failure and prevent its recurrence. d. Staff confirmed on 6/21/18 at around 10:30 am, the laboratory did not review and evaluate unsatisfactory PT results received in 2017. 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 a review of the quality assessment (QA) plan, personnel competency assessment records, and staff interview, the technical consultant failed in 2018 to evaluate the competency of all testing personnel who perform moderate complexity testing using the Medonic M Series hematology analyzer and approximately 1135 patients are tested annually. Findings include: a. The QA plan states competency assessments will be directly observed by the Laboratory Director in conjunction with the Clinic Lead. b. Competency assessment records for 2018 showed 10 of 10 testing personnel (#2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 on Form CMS-209) were evaluated on 6/18 /18 by a testing personnel not qualified to be a technical consultant. c. On 6/21/18 at around 10:30 am, staff confirmed the 2018 competency assessments were not performed by a qualified technical consultant. -- 2 of 2 --