Physical Medicine Rehabilitation And Consultant

Summary Statement of Deficiencies D5781

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 record review and interview with the technical consultant, the laboratory failed to attest that proficiency testing samples were tested in the same manner as patient specimens for one (2024 Chemistry Miscellaneous 1st Event) of four proficiency testing events reviewed. Findings include: 1. A review of the laboratory's proficiency testing records revealed 2024 Chemistry Miscellaneous 1st Event's attestation page had not been signed by the testing personnel and the laboratory director documenting that proficiency testing samples were tested in the same manner as patient specimens. 2. An interview on 10/28/24 at 12:06 pm with the technical consultant confirmed an attestation statement had not been completed for the proficiency testing event listed above. D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, 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 -- materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: . Based on record review and interview with the technical consultant, the laboratory failed to have an operating analyzer to perform its volume of testing for two (February 2024 to April 2024) months the EasyRA urine toxicology analyzer was not in operation. Findings include: 1. A review of 12 patient test records revealed three patients with the following turnaround timeframes for qualitative urine toxicology testing: a. Patient 7 had a specimen collected 3/12/24, was tested and reported on 4/16 /24. b. Patient 11 had a specimen collected 2/27/24, was tested and reported on 4/17 /24. c. Patient 12 had a specimen collected 2/28/24, was tested and reported on 4/17 /24. 2. An interview on 10/18/24 at 10:29 am with the technical consultant revealed the laboratory's the EasyRA urine toxicology analyzer was down from 2/22/24 to 4/16 /24. Patient specimens were held to be performed once the instrumentation was repaired. D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on observations, record review, and interviews, the laboratory failed to verify its qualitative urine toxicology testing at least twice annually (refer to D5217), failed to follow its specimen labeling policies (refer to D5311 A), failed to follow its specimen storage and preservation policies (refer to D5311 B), failed to follow its specimen processing procedures (refer to D5311 C), failed to monitor laboratory, refrigerator and freezer temperatures to ensure proper storage of reagents, specimens, and reliable analyzer operations (refer to D5413), failed to perform control procedures at least each day of patient testing (refer to D5445), failed to perform

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to have test requests for qualitative urine toxicology testing for patients for 7 (Patients 8605, 9167, 9467, 5553, 9889, 5236, and 8907) of 7 patient test records reviewed. Findings include: 1. A review of patient test records revealed the following patients had qualitative urine toxicology testing performed by the laboratory with a lack of test request available: a. Patient 8605 had testing performed on 6/15/22. b. Patient 9167 had testing performed on 7/27/22. c. Patient 9467 had testing performed on 8/25/22. d. Patient 5553 had testing performed on 10/30/22. e. Patient 9889 had testing performed on 11/17/22. f. Patient 5236 had testing performed on 12/13/22. g. Patient 8907 had testing performed on 1/29/23. 2. An interview on 2/15/23 at 9:36 am with the Technical Consultant confirmed test requests for the patients listed above were not available. 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 observation and interview with the Technical Consultant, 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 -- failed to ensure its EasyRa Surfactant reagent was not used past its expiration date for 3 (November 2022 to February 2023) of 3 months since the reagent had expired on 11 /9/22. Findings include: 1. The surveyor observed 6 bottles of EasyRa Surfactant reagent in the laboratory with the expiration date of 11/9/22 on 2/15/23 at 8:45 am. 2. An interview on 2/15/23 at 9:43 am with the Technical Consultant revealed the expired reagent was in use and is added to the reagent water each date of patient testing. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) 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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to perform control procedures each date of patient testing for its qualitative urine toxicology testing for 1 (8/25/22) of 7 patient testing dates reviewed. Findings include: 1. A review of patient test records and quality control records revealed on a lack of quality control performance on 8/25/22 when patients had been tested. 2. A review of the laboratory's "Barbiturate (BARB)", "Benzodiazepine (BENZ)", "Cocaine (COCM)", "Methadone (METD)", "Opiate (OP)", "Amphetamine (AMPH)", and "Oxycodone (OXYC)" procedures revealed a section stating, "Test a positive and negative control each day of testing." 3. An interview on 2/15/23 at 10:09 am with the Technical Consultant confirmed patient testing was performed when quality control had not been performed. A total of 10 patients had received testing on 8 /25/22. D5785

Summary Statement of Deficiencies 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 record review and interview with the Technical Consultant (TC), the laboratory failed to have a written procedure manual available to laboratory personnel for 1 (April 2022 to May 2022) of 1 month reviewed. Findings include: 1. A review of the laboratory's documentation on 5/19/22 revealed a lack of procedure manual. 2. An interview on 5/19/22 at 9:50 am with the TC revealed the procedure manual was at their office during the creation of the laboratory's allegation of compliance and was not present at 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 1 --

Summary Statement of Deficiencies D0000 The purpose of this unannounced survey was for complaint #MI00126842. The Department of Licensing and Regulatory Affairs has evaluated this facility and determined that it is not in compliance with CLIA regulations (42 CFR Part 93, effective April 24, 2003) for the following Condition: 493.1213 Condition: Toxicology 493.1409 Condition: Laboratories performing moderate complexity testing; Technical Consultant D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director (LD), the laboratory failed to retain proficiency testing records for at least 2 years for 1 (2020 Event 2 Chemistry Miscellaneous) of 4 proficiency testing events reviewed. Findings include: 1. A review of the laboratory's American Proficiency Institute (API) proficiency testing records revealed a lack of documentation of the results from the proficiency testing provider for Chemistry Miscellaneous Event 2 in 2020 performed on 5/7/20. 2. The surveyor requested the proficiency testing results for the Chemistry Miscellaneous Event 2 in 2020 on 3/22/22 at 4:27 pm and they were not made available. 3. An interview on 3/22/22 at 4:27 pm with the LD confirmed the laboratory did not retain proficiency testing results for at least 2 years. D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This CONDITION is not met as evidenced by: . Based on record review and interviews, the laboratory failed to meet the requirements for the specialty Toxicology as specified in 493.1230 through 493.1256 and 493.1281 through 493.1299. Findings include: 1. The laboratory failed to follow its policy for patient specimen storage and preservation. Refer to D5311. 2. The laboratory failed to ensure results of control materials met established criteria for acceptability before reporting patient test results. Refer to D5481. 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 record review and interview with the Laboratory Director (LD), the laboratory failed to verify the accuracy of its toxicology analytes not scored by the American Proficiency Institute (API) proficiency testing program for 1 (2021 Chemistry Miscellaneous Event 2) of 4 proficiency testing events reviewed. Findings include: 1. A review of the laboratory's API proficiency testing records revealed the laboratory did not participate in the Chemistry Miscellaneous Event 2 in 2021, receiving a score of 0% for Amphetamines, Barbiturates, Benzodiazapines, Cocaine Metabolites, Methadone, Opiates, and Oxycodone. 2. A review of the laboratory's "Proficiency Testing " procedure revealed a section stating, "When PT results are unsatisfactory, we will evaluate the results and take appropriate