Center Of Health/Out-Patient Surgery Center

Summary Statement of Deficiencies D0000 A Recertification survey was conducted March 12, 2025 at Center of Health/Out- Patient Surgery Center - CLIA ID # 19D2198833. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard level deficiencies were cited. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS-209 (Laboratory Personnel Report) form, policies, and proficiency testing records; as well as interview with personnel, the laboratory failed to ensure proficiency testing samples were rotated among all testing personnel performing routine chemistry and hematology testing for three (3) of three (3) events reviewed. Findings: 1. Review of the laboratory's CMS-209 form revealed the following four (4) personnel served as testing personnel: a) Personnel 1 b) Personnel 2 c) Personnel 3 d) Personnel 4 2. Review of the laboratory's policy "Blood Gas Laboratory: Proficiency Testing" revealed "As feasible, the analysis of proficiency testing samples will be rotated among all testing personnel." 3. Review of the laboratory's 2024 College of American Pathologists (CAP) proficiency testing records revealed Personnel 1 performed all samples in each of the following three (3) testing events: a) AQH-A 2024 b) AQH-B 2024 c) AQH-C 2024 4. In interview on March 12, 2025 at 12:09 p.m., the Technical Consultant confirmed Personnel 1 performed all testing for the three (3) proficiency testing events in 2024 as identified above. D2009 TESTING OF PROFICIENCY TESTING SAMPLES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- CFR(s): 493.801(b)(1) (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 laboratory's proficiency testing records and interview with personnel, the laboratory failed to ensure the Testing Personnel signed the attestation statement for two (2) of four (4) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's College of American Pathologists (CAP) proficiency testing records revealed the Testing Personnel did not sign the attestation statement for the following two (2) testing events: a) AQH-A 2024 b) AQH-B 2024 2. In interview on March 12, 2025 at 12:09 p.m., the Technical Consultant confirmed the testing personnel did not sign the attestation statements for the PT events identified above. 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's policies, CMS-209 form, and personnel records; as well as interview with personnel, the laboratory failed to establish written policies and procedures to assess competency of the Technical Consultant. Findings: 1. Review of the laboratory's policy "Personnel Policies, Competency, & Files" revealed the laboratory did not include procedures, including, but not limited to frequency of performance of competency assessments for the Technical Consultant. 2. Review of the laboratory's CMS-209 (Laboratory Personnel Report) form revealed Personnel 5 served as Technical Consultant. 3. Review of personnel records for Personnel 5 revealed a competency assessment was not performed for her role as Technical Consultant. 4. In interview on March 12, 2025 at 10:24 a.m., the Technical Consultant confirmed the laboratory did not have a policy related to competency assessment of the Technical Consultant. She stated she thought a competency was performed but the laboratory could not provide documentation of performance. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with laboratory personnel, the laboratory failed to ensure laboratory policies and procedures were approved and signed by the laboratory director. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory director did -- 2 of 9 -- not approve and sign all policies and procedures in use to include, but not limited to, the following policies: a) EPOC Blood Gas Quality Assurance Program b) Blood Gas Laboratory: Proficiency Testing c) Quality Control EPOC 2. In interview on March 12, 2025 at 11:48 p.m., the Laboratory Director confirmed he did not approve and sign the policies identified above. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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: I. Based on review of the laboratory's policies and temperature logs and interview with personnel, the laboratory failed to document the room temperature and humidity for forty-four (44) of four hundred twenty-four (424) days reviewed. Findings: 1. Review of the laboratory's policy "Environmental Monitoring" revealed "Room temperature and humidity are monitored and documented daily in the CFH." 2. Review of the laboratory's "Environmental Monitoring Log" from January 2024 to February 2025 for the "CFH Peri Op" area revealed temperature and humidity were not documented on the following dates: January 3, 2024 January 9, 2024 January 17, 2024 January 24, 2024 February 14, 2024 February 20, 2024 February 28, 2024 March 7, 2024 March 14, 2024 March 22, 2024 March 25, 2024 April 5, 2024 April 10, 2024 April 18, 2024 April 26, 2024 April 29, 2024 May 9, 2024 May 14, 2024 May 23, 2024 May 30, 2024 June 18, 2024 June 26, 2024 July 18, 2024 July 22, 2024 July 24, 2024 August 2, 2024 August 5, 2024 August 13, 2024 August 16, 2024 August 21, 2024 August 28, 2024 September 9, 2024 September 12, 2024 September 20, 2024 September 23, 2024 September 30, 2024 October 24, 2024 October 28, 2024 November 4, 2024 November 26, 2024 November 27, 2024 November 29, 2024 December 16, 2024 February 13, 2025 3. In interview on March 12, 2025 at 1:34 p. m., Personnel 4 confirmed the laboratory did not document the temperature and humidity on the dates identified above. II. Based on review of the laboratory's policies and temperature logs and interview with personnel, the laboratory failed to document the refrigerator temperature for eleven (11) of two hundred forty-two (242) days reviewed. Findings: 1. Review of the laboratory's policy "Environmental Monitoring" revealed "On a daily basis record all refrigerator temperatures." 2. Review of the laboratory's "Environmental Monitoring Log" from January 2024 to June 2024 and November 2025 to December 2025 for the "PAE Fridge" revealed the refrigerator temperature was not documented on the following dates: April 5, 2024 April 10, 2024 April 18, 2024 April 26, 2024 May 9, 2024 May 23, 2024 May 30, 2024 June 18, 2024 June 26, 2024 November 29, 2024 December 16, 2024 3. In interview on March 12, 2025 at 3:37 p.m., Personnel 4 confirmed the laboratory did not document the refrigerator temperature on the dates identified above. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) -- 3 of 9 -- (d) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on observation; review of the laboratory's policies, quality control records, and patient test records; as well as interview with personnel, the laboratory failed to perform quality control (QC) every thirty (28) days as required by the laboratory on the EPOC analyzer for two (2) of fourteen (14) months reviewed. Findings: 1. Observation by surveyor on March 12, 2025 at 10 a.m. during the laboratory tour revealed the laboratory utilized the EPOC analyzer for pH, CO2, pO2, Sodium, Potassium, Calcium, Glucose, Chloride, Creatinine, Blood urea nitrogen, Hematocrit, and Hemoglobin testing. 2. Review of the laboratory's Individualized Quality Control Plan (IQCP) revealed "Level 1 and Level 3 run QMonth." 3. Review of the laboratory's policy "Quality Control EPOC" revealed "Level 1, Level 3, Level A, & Level B run QMonth." 4. In interview on March 12, 2025 at 1:55 p.m., the Technical Consultant stated QC is performed every twenty-eight (28) days on the EPOC analyzer unless the due date falls on a weekend. 5. Review of the laboratory's quality control records from January 2024 through February 2025 revealed the laboratory did not perform quality control every twenty-eight (28) days as follows: a) External QC performed April 2, 2024 and May 6, 2024 (Due April 30, 2024 - six (6) days overdue) b) External QC performed May 6, 2024 and June 7, 2024 at 1353 (Due June 3, 2024 - four (4) days overdue) 6. Review of patient test records revealed the following patients were tested and reported without QC performed as required: a) Patients tested between May 1 and May 6, 2024: Patient 000102092378: May 3, 2024 Patient 000102099232: May 3, 2024 Patient 000102106864: May 3, 2024 b) Patients tested between June 4 and June 7, 2024 Patient 000102123942: June 7, 2024 Patient 000102107952: June 7, 2024 Patient 000102118606: June 7, 2024 Patient 000102094916: June 7, 2024 7. In interview on March 12, 2024 at 2:45 p.m., the Technical Consultant confirmed QC was not performed as identified above. D5783