(a) Audits.
  (1) Audits are non-disciplinary reviews:
    (A) conducted as an off-site document review; and
    (B) initiated by a Board subpoena request for documents as necessary to determine or verify:
      (i) exemption from application of Chapter 168 of the Act;
      (ii) need to certify as a PMC; or
      (iii) no certification requirement.
  (2) A total of 30 patients records will be reviewed during an audit. The relevant portions of the 30 records to be reviewed are the initial visit; last two office visits; referrals; procedures notes/logs; consultation requests; consult notes, and prior authorization records, if any. These records will be a combination of new patients seen in one of the last two calendar months and established patients seen in the previous six calendar months with a minimum of 10 records for each type.
  (3) Documents requested may also include those used to verify personnel training, qualifications, and general compliance with Chapter 168 of the Act and related rules.
  (4) Upon completion of the audit, the Board will issue a notice of determination to the audited clinic owner. The notice of determination will specify:
    (A) Deficiencies, if any; and
    (B) If necessary, any corrective actions the clinic must take, including a requirement to apply for certification.
(b) Inspections.
  (1) Inspections are non-disciplinary reviews:
    (A) done on both certified and non-certified clinics in accordance with Section 168.052 of the Act; and
    (B) usually conducted on-site but may also be off-site, as determined by Board staff.
  (2) The following patient records will be reviewed during an inspection, as determined by Board staff: patients seen during two calendar months out of the previous eight months from the date of the inspection.
  (3) For certified pain management clinics, inspections are conducted to verify compliance with Chapter 168 of the Act and the applicable laws and rules.
  (4) For non-certified clinics, inspections are conducted to determine if the clinic is subject to be certified under Chapter 168 of the Act.
  (5) In accordance with Section 168.052(b) of the Act, to initiate an inspection the Board has determined the following grounds can be utilized, but are not limited to:
    (A) PMP reports;
    (B) patient population analysis, including review of patients coming from outside the immediate geographic location of the clinic;
    (C) common addresses for multiple patients;
    (D) notices to providers from the Pharmacy Board regarding a patient having multiple prescribing providers;
    (E) complaints about the clinic and its operation; and
    (F) law enforcement reports regarding providers or patients.
  (6) Notice of intent to inspect will be provided at least five days in advance unless such timing would compromise the inspection.
  (7) Notice of inspection results will be provided in writing to the clinic.
  (8) If the inspection determines instances of non-compliance, the Board will determine appropriate action to obtain compliance.
(c) Investigations may be conducted due to a complaint received or initiated by the Board. An investigation will be conducted in accordance with the provisions of this Title and all applicable Board rules.

Source Note: The provisions of this §195.5 adopted to be effective November 9, 2022, 47 TexReg 7412