Rehabilitative Health Services Medical Clinic

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 a review of proficiency testing (PT) records from the American Association of Bioanalysts (AAB) and an interview with the laboratory lead on 5/17/2024, the laboratory failed to sign PT attestations for 2022, 2023 and 2024. The findings include: 1. A review of PT records from AAB for events one and two in 2023 identified that the testing personnel failed to sign the attestation statements for complete blood count (CBC) testing. 2. A review of PT records from AAB for event three in 2023 identified that the laboratory director and testing personnel failed to sign the attestation statement for CBC testing. 3. A review of PT records from AAB for event one in 2024 identified that the laboratory director and testing personnel failed to sign the attestation statement for CBC testing. 4. An interview with the laboratory lead on 5/17/2024 at 9:32 am confirmed that the laboratory director and testing personnel failed to sign attestation statements for the above events. 5. The laboratory reports performing 17,750 hematology tests annually. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: 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 -- Based on a review of proficiency testing (PT) records from the American Association of Bioanalysts (AAB) and an interview with the laboratory lead on 5/17/2024, the laboratory director failed to review PT results for 2023. The findings include: 1. A review of PT records from AAB for events two and three in 2023 identified that the laboratory director failed to review and evaluate graded results for complete blood count (CBC) testing. 2. An interview with the laboratory lead on 5/17/2024 at 9:32 am confirmed that the laboratory director failed to review and evaluate the graded PT results in 2023. 3. The laboratory reports performing 17,750 hematology tests annually. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a lack of documentation for the verification of accuracy for urine drug screen testing and an interview with the laboratory lead on 5/17/2024, the laboratory failed to ensure accuracy at least twice annually in 2023. The findings include: 1. A lack of verification of accuracy documentation for urine drug screen testing identified that the laboratory failed to ensure testing accuracy twice in 2023 for the following analytes: Alcohol, Fentanyl, Tramadol, amphetamine, buprenorphine, benzodiazepine, cocaine, ecstasy, methamphetamine, opiate, methadone, oxycodone and marijuana. 2. An interview with the laboratory lead on 5/17/2024 at 10:52 am confirmed the above finding. 3. The laboratory reports performing 31,850 toxicology tests annually. 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 a lack of quality control (QC) performance documentation for urine drug screen testing and an interview with the laboratory lead on 5/17/2024, the laboratory failed to ensure accurate test results each day of patient testing. The findings include: 1. A lack of QC documentation for urine drug screen testing identified that the laboratory failed to perform QC for the following analytes: alcohol, Fentanyl, Tramadol, amphetamine, buprenorphine, benzodiazepine, cocaine, ecstasy, methamphetamine, opiate, methadone, oxycodone and marijuana each day of patient testing 2. An interview with the laboratory lead on 5/17/2024 at 10:52 am confirmed the above finding. 3. The laboratory reports performing 31,850 toxicology tests annually. -- 2 of 3 -- D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on a lack of documentation for the verification of performance specifications for urine drug screens and an interview with the laboratory lead on 1/17/2024, the technical consultant failed to ensure test performance specifications were established and verified before beginning patient testing. The findings include: 1. A lack of documentation for the verification of performance specifications for urine drug screen testing identified that the laboratory failed to verify precision, accuracy and reportable range for the following analytes: Alcohol, Fentanyl, Tramadol, amphetamine, buprenorphine, benzodiazepine, cocaine, ecstasy, methamphetamine, opiate, methadone, oxycodone and marijuana. 2. An interview with the laboratory lead on 5 /17/2024 at 10:52 am confirmed the above finding. 3. The laboratory reports performing 31,850 toxicology tests annually. 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 Centers for Medicare and Medicaid Services (CMS) 209 personnel form, laboratory procedures, training and competency assessment records and an interview with the laboratory lead on 5/17/2024, the technical consultant (TC) failed to follow policies and procedures to assess testing personnel (TP) competency. The findings include: 1. The CMS 209 identified six (6) testing personnel (TP) performing complete blood count (CBC) testing. Four (4) of the six (6) TP have start dates after the previous inspection on 6/23/2022. 2. A review of training and competency assessment records identified that the laboratory failed to have annual competency assessments for complete blood count (CBC) testing for three (3) of three (3) TP in 2023. 3. A review of training and competency assessment records identified that the laboratory failed to have six month competency assessments for CBC testing for two (2) of two (2) TP in 2023. 4. An interview with the laboratory lead on 5/17 /2024 at 9:05 am confirmed the TC failed to perform competencies in 2023. 5. The laboratory reports performing 17,750 hematology tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on a random review of patient records and an interview with testing personnel 1 (TP1) on 1/26/2021, the laboratory failed to retain or be able to retrieve a copy of the original test report for a patient for at least two (2) years after the date of reporting. The findings include: 1. A random review of patient records revealed that the laboratory was unable to retrieve patient AB's complete blood count (CBC) results from 10/13/2020. They were unable to retrieve the instrument printout and the results had not been uploaded into the patient chart. 2. An interview with testing personnel 1 (TP1) on 1/26/2021 at 2:30 pm confirmed that the laboratory was unable to obtain CBC results for patient AB performed on 10/13/2020. 3. The laboratory reports performing 2955 CBC tests annually. 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 personnel training and competency records, the Centers for Medicare and 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 -- Medicaid Services (CMS) 209 personnel form, and interview with laboratory testing personnel 1 (TP1) on 1/26/21, the laboratory failed to establish and follow written policies and procedures for initial training and assessment of new employees. The findings includes: 1. The laboratory's CMS-209 form identifies one (1) of four (4) testing personnel performing moderate complexity testing is new and did not have initial training documented for complete blood count (CBC) testing. 2. The laboratory did not establish policies or procedures for initial training and assessment of new employees. 3. An interview with testing personnel 1 (TP1) on 1/26/21 at 1:00 pm confirmed that the laboratory did not have initial training documentation for the one new testing personnel and did not have an established policy and procedure for initial training and assessment of new employees. 4. The laboratory reports performing 2955 CBC tests annually. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Quaility Control (QC) records for the pocH-100i and an interview with the testing personnel 1 (TP1) on 1/26/2021 the laboratory failed to monitor over time the accuracy and precision of test performance of the pocH-100i that may be affected by changes in test system performance and environmental conditions, and variance in operator performance. The findings include: 1. The QC records for the pocH-100i revealed that the laboratory failed to monitor the QC of complete blood counts (CBC) over time to look for trends or shifts that may affect patient results. 2. The testing personnel confirmed by interview on 1/26/2021 at 1:29 pm that they monitor QC daily for CBC tests but that they do not monitor the QC over time for trends or shifts. 3. The laboratory reports performing 2955 CBC tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a record review and an interview with the laboratory lead, revealed the laboratory failed to enroll in proficiency testing (PT) for the specialty of hematology for complete blood counts (CBCs) since the start of patient testing in October 2016. Findings: 1. A review of documents revealed the laboratory failed to enroll in PT for the specialty of hematology CBC analytes since the start of patient testing in 2016. 2. An interview on September 19, 2018 at 3:30 PM, with the laboratory lead and laboratory director, confirmed the laboratory failed to enroll in PT for CBC analytes. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- Based on a record review and an interview with the laboratory lead and director, the laboratory failed to retain external quality control data from the Sysmex pocH-100 since the start of patient testing in October 2016. Findings: 1. A review of quality control records revealed the laboratory failed to retain all three levels of quality control data from the Sysmex pocH-100 complete blood count analyzer since October 2016. 2. An interview on September 19, 2018 at 3:45 PM, with the laboratory lead and laboratory director, confirmed the laboratory failed to retain all quality control data printouts from the CBC analyzer. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a record review and an interview with the laboratory lead and laboratory director, the laboratory failed to monitor and evaluate the overall quality of the general laboratory system for the specialty of hematology since October 2016. Refer to D5203, D5209, and D5217. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory lead and laboratory director, the laboratory failed to establish and write procedures and policies that ensure positive patient identification and integrity of a patient's blood specimen since the start of patient testing in October 2016. Findings: 1. A review of records revealed the laboratory failed to establish and write policies and procedures to ensure positive patient identification from the time of collection to the reporting of test results. 2. An interview on September 19, 2018 at 4:00 PM, with the laboratory lead and laboratory director, confirmed the laboratory failed to establish procedures that ensure positive patient identification from the time of collection to the final reporting of patient test results. 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. -- 2 of 12 -- This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory lead, the laboratory failed to establish and write procedures and policies to assess testing personnel competency in the specialty of hematology performing complete blood counts (CBCs) and microscopic fungal examinations using potassium hydroxide (KOH) since the start of patient testing in October 2016. Findings: 1. A review of personnel records revealed the laboratory failed to establish and write policies and procedures to evaluate the competency for 6 out of 6 testing personnel listed on the CMS-209 Personnel Report form performing CBCs and KOH examinations. 2. An interview on September 19, 2018 at 3:10 PM, with the laboratory lead, confirmed the laboratory failed to write and follow procedures to evaluate the competency of testing personnel. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory lead, the laboratory failed to verify the accuracy of microscopic fungal examinations using potassium hydroxide (KOH) at least twice a year since the start of patient testing in October 2016. Findings: 1. A review of records revealed the laboratory failed to verify the accuracy of microscopic fungal examinations using KOH at least twice a year since October 2016. 2. An interview on September 19, 2018 at 4:20 PM, with the laboratory lead, confirmed the laboratory failed to verify the accuracy at least twice a year the microscopic examination of fungal elements from the skin. 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 a record review and an interview with the laboratory lead, the laboratory failed to have a written request or electronic request for complete blood counts (CBCs) ordered and performed on 4 patient specimens on September 4, 2018. Findings: 1. A review of patient reports revealed the laboratory failed to have a written or electronic request for 4 patient CBC tests performed on patient specimens. 2. An interview on September 19, 2018 at 4:20 PM, with the laboratory lead, confirmed the laboratory failed to receive a written test request for 4 patient CBCs performed on September 4, 2018. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) -- 3 of 12 -- Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory lead and laboratory director, the laboratory failed to establish and write policies and procedures for patient preparation, specimen collection and labelling, specimen storage and transportation, specimen processing, acceptability and rejection since the start of patient testing in October 2016. Findings: 1. A review of records in the laboratory revealed the laboratory failed to establish and write procedures and policies to provide guidance to testing personnel in the preanalytic processing steps for a patient's specimen. 2. An interview on September 19, 2018 at 4:45 PM, with the laboratory lead and laboratory director, confirmed the laboratory failed to establish and write procedures for the preanalytic specimen processing steps. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record reviews, the laboratory failed to monitor, evaluate, and correct problems in the analytic system since the start of patient testing in October 2016. Refer to D5401, D5413, D5417, D5421, D5433, and D5437. 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 lead and laboratory director, the laboratory failed to write policies and procedures for all tests performed in the laboratory since October 2016. Findings: 1. A review of records revealed the laboratory failed to write procedures for complete blood count testing and microscopic examinations of fungal skin specimens since October 2016. 2. An interview on September 19, 2018 at 4:45 PM, with the laboratory lead and laboratory director, confirmed the laboratory failed to establish and write procedures for tests performed in the laboratory. -- 4 of 12 -- D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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: Based on a record review and an interview with the laboratory lead, the laboratory failed to document the room temperature of the laboratory and the refrigerator where quality control material for complete blood counts (CBCs) are stored since the start of patient testing in October 2016. Findings: 1. A review of the records for the laboratory revealed the laboratory failed to record the temperature of the laboratory room and refrigerator where quality controls for the Sysmex pocH-100 complete blood count (CBC) are stored and tested since October 2016. 2. An interview on September 19, 2018 at 3:45 PM, with the laboratory lead, confirmed the laboratory staff failed to record the temperature of the laboratory and the refrigerator where CBC quality controls are stored and tested. 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 an observation and an interview with the laboratory lead, the laboratory failed to use the Sysmex pocH-100 complete blood count (CBC) external quality control materials within the timeframe established by the manufacturer since October 2016. Findings: 1. An observation of the laboratory refrigerator on September 19, 2018 revealed the laboratory stored Eightcheck-3WP tri-level quality control materials that were used past their expiration date when opened for testing. 2. An interview on September 19, 2018 at 3:35 PM, with the laboratory lead, confirmed the external quality control material for CBC failed to be used within the expiration date specified by the manufacturer and that the expired controls were being used when testing and reporting patient CBC specimens. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for -- 5 of 12 -- the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory lead, the laboratory failed to perform and document the accuracy and precision of the Sysmex pocH-100 complete blood count (CBC) hematology analyzer prior to reporting patients results on October 16, 2016. Findings: 1. A record review of the installation verification activities for the Sysmex pocH-100 CBC analyzer revealed the laboratory failed to perform accuracy and precision studies before reporting patient results. 2. An interview on September 19, 2018 at 4:15 PM, with the laboratory lead, confirmed the laboratory failed to verify the accuracy and precision of the CBC analyzer prior to reporting patient results since October 16, 2016. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory lead, the laboratory failed to establish and document unscheduled maintenance or preventative maintenance activities for the Sysmex pocH-100 complete blood count (CBC) hematology analyzer since the start of patient testing in October 2016. Findings: 1. A record review of the laboratory procedures revealed the laboratory failed to establish a