Mountain Lakes Medical Center

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on December 17, 2024. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 CFR 493.1441 Condition: HIGH COMPLEX Laboratory Director 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 review of the CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory proficiency 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 -- testing (PT) participation for Compatibility testing in 2024 event 2, resulting in an initial unsuccessful participation. Refer to D 2173 D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory participation in the 2nd event of 2024 resulting in an initial unsuccessful participation for compatibility testing. Findings: 1. A review of Casper Report 155 revealed the laboratory failed Compatibility testing on the following: 2024 Event 2 Score 40% 2. A review of the laboratory's API Report confirmed the laboratory failed compatibility testing with the aforementioned score D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CMS CASPER 155 report and review of American Proficiency Institute (API) report, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6089 D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the CMS CASPER Report 155 and the American Proficiency Institute (API) 2024 event # 2 PT evaluation report, the laboratory director failed to ensure successful proficiency testing performance in compatibility testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 06, 2024. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on the inspection of the reagents in the main refrigerator during the laboratory tour and staff interview, the laboratory's Testing Personnel (TP) did not label in-use control material appropriately at the time of survey on 03/06/2024. Findings; 1.) Observation of the reagents in the reagent refrigerator revealed that the (TP) did not place an open and/ or expiration date on the Chemistry Multi Qual Control vials (Levels 1 & 2) in- use, on day of survey , 03/06/2024.. 2,) Testing Personnel (TP) poured Hemoglobin (HgbA1C) Controls levels 1 & 2 into unlabeled insert cups without proper labelling to identify the contents of the insert cups on day of survey, 03 /06/2024. 3.) Interviews with staff and laboratory manager, at approximately 10:45 am, in the lab, confirmed the findings on the day of survey, 03/06/2024. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory 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 -- 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: Observation during the laboratory tour, maintenance documents review and staff interviews, revealed the laboratory failed to perform annual calibrations for its pipettes as required by the Standard Operating Procedures (SOP) in 2023. Findings: A review of maintenance and equipment calibration records, on the day of survey, 03/06 /2024, revelaed the following: 1.) MLA pipettes (10ul, 25ul, 50ul, 100ul, 700ul, 1000ul) had the calibration expiration date of 03/31/2023. 2.) ID TIP Master brand pipettes (25ul, 50ul, 125ul) had the calibration expiration date of 03/31/2023. 3.) Interviews with staff and laboratory manager (TP# 7 CMS 209) in the conference room, on 03/06/2024, at approximately 3:00 PM confirmed the above findings. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: A review of the Chemistry daily Quality Control (QC) and maintenance records confirmed that the laboratory released patient results for two (2) out of nineteen (19) patients without evidence of (QC) being performed in 2024. Findings: 1.) A review ofthe daily chemistry (QC) from Dimensions EXL analyzer review revealed, control records and patient testing records for the analyte FT4 from 01/01/2024 through 03/05 /2024 confirmed two (2) out of nineteen (19) patients tested were resulted without evidence of (QC) being performed on the day of testing. Patients affected were MR*77604, resulted on 02/02/2024, and MR*59932, resulted on 03/04/2024. 2.) An interview with the laboratory manager (TP#7CMS 209), in the conference room, at approximately 3:00 PM, on March 06, 2024 confirmed the above findings in 2024.. D6075 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(6) Each individual performing moderate complexity testing must document all

Summary Statement of Deficiencies D0000 On May 26, 2022 an off site followup review was completed. The report revealed that

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on April 6, 2022. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecutive events (3rd event of 2021 and 1st event of 2022), 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 -- resulting in the first unsuccessful occurrence for Endocrinology # 525 including: Free Thyroxine (Free TY) #545. Findings include: Refer to D 2099 D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecitive events (3rd event of 2021 and 1st event of 2022), resulting in the first unsuccessful performance for Free thyroxine analyte # 545. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 545 Free Thyroxine on event 3 of 2021 with a score of 60% and event 1 of 2022 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed Free thyroxine on Event 3 of 2021 and event 1 of 2022 resulting in the first unsuccessful performance. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to maintain satisfactory performance in two consecutive events (3rd event of 2021 and 1st event of 2022), resulting in the first unsuccessful occurrence for Endocrinology # 525 including: Free Thyroxine (Free TY) #545. Findings include: Refer to D 6016 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's -- 2 of 3 -- proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two consecutive events (3rd event of 2021 and 1st event of 2022), resulting in the first unsuccessful occurrence for Free Thyroxine (Free TY), analyte # 545. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #545 , Free TY on event 3 of 2021 with a score of 60% and event 1 of 2022 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed Free TY on Event 3 of 2021 and 1 of 2022, resulting in the first unsuccessful performance. -- 3 of 3 --